ISO 13485: What You Need to Know to Build a Quality Management Systems for Medical Devices

ZimmerPeacock
22 Mar 202313:11

Summary

TLDRThis video discusses the importance of a quality management system (QMS) in the medical device industry, emphasizing the need for compliance with regulations like MDR and IVDR. It introduces ISO 13485 as a key standard for developing and maintaining a QMS, covering aspects like documentation control, design and development, risk analysis, and change control to ensure product quality and regulatory compliance.

Takeaways

  • πŸ˜€ Quality, cost, and time are the three main factors in the Air Force triangle for a project, aiming for the 'Utopia' balance of high quality, low cost, and short time to market.
  • πŸš€ Starting with a quality management system (QMS) early in the project can expedite market entry and ensure regulatory compliance.
  • πŸ“š A QMS should follow the development stages of a product, ensuring all necessary documentation for regulatory approval is in place.
  • πŸ₯ Compliance with regulations like MDR for medical devices or IVDR for in vitro diagnostic devices is mandatory for EU market entry.
  • πŸ‡ΊπŸ‡Έ In the USA, medical devices must adhere to 21 CFR part 820 for FDA approval.
  • 🌐 ISO 13485 is an international standard for QMS in medical device manufacturing, development, and distribution, adapted to comply with various regulations.
  • πŸ“‹ A QMS includes documents like a quality policy, quality manual, and organization chart, which describe the company's processes and structure.
  • 🎯 Quality goals should be defined annually and tracked to measure improvement against the previous year.
  • πŸ“ Document and record control processes are crucial for maintaining and tracking all documents produced throughout the product lifecycle.
  • πŸ” Risk analysis is a critical component of the QMS, ensuring that potential risks associated with the product are identified and managed.
  • πŸ› οΈ Design reviews, verification, and validation are essential steps in the development of medical devices to ensure they meet specifications and are safe for use.
  • πŸ›‘οΈ Change control processes are vital to ensure that any modifications to the product do not introduce new risks or affect existing ones.
  • πŸ›’ Purchasing processes, including supplier evaluation and approval, are part of the QMS to ensure the quality of purchased materials.

Q & A

  • What is the main topic discussed in the video script?

    -The main topic discussed in the video script is the relationship between regulatory compliance, quality, and cost in the context of medical device manufacturing, with a focus on establishing a quality management system (QMS).

  • Why is it important to have a quality management system in place early in a project?

    -Having a quality management system in place early in a project helps to ensure that all documentation required by regulations and authorities is available, allowing for a quicker and more efficient market entry of medical devices.

  • What does the acronym 'MDR' stand for in the context of the script?

    -In the script, 'MDR' stands for Medical Device Regulation, which is a regulation that medical device manufacturers must comply with to place their products on the market in the EU.

  • What is the significance of the 'Air Force triangle' mentioned in the script?

    -The 'Air Force triangle' is a conceptual model that illustrates the relationship between quality, cost, and time. It suggests that to achieve the best outcome, one must strive for the highest quality product in the shortest time possible at the lowest cost.

  • What is ISO 13485 and how does it relate to medical device manufacturers?

    -ISO 13485 is an international standard specifically designed for medical device manufacturers, developers, and distributors. It provides a framework for a quality management system that helps ensure regulatory compliance with various medical device regulations.

  • What are some of the key documents that a quality management system according to ISO 13485 should include?

    -Key documents in an ISO 13485 compliant QMS include a quality policy, a quality manual, an organization chart, quality goals, and a document and record control process.

  • Why is risk analysis important in the development of medical devices?

    -Risk analysis is crucial in medical device development to identify potential risks associated with the product's use and to ensure that these risks are properly managed and mitigated to protect users and comply with regulatory requirements.

  • What is the purpose of a product development plan in the context of medical device manufacturing?

    -A product development plan outlines the process and milestones for developing a new medical device. It helps to organize the development stages, allocate resources, and track progress towards meeting the product's specifications and regulatory requirements.

  • What is the importance of change control in the production of medical devices?

    -Change control is essential to ensure that any modifications to a medical device do not introduce new risks or affect existing ones. It is a process that manages, reviews, and approves changes to ensure ongoing compliance and product safety.

  • How does the script suggest ensuring compliance with regulatory requirements for medical devices in the US?

    -The script suggests that manufacturers should adhere to 21 CFR Part 820, which is the FDA's regulation governing the approval and quality system requirements for medical devices in the US.

  • What is the role of training in the quality management system as described in the script?

    -Training is important to ensure that team members have the necessary knowledge and skills to perform their roles effectively. The script emphasizes the need for a defined training program, role descriptions, and records of training completion to meet ISO 13485 requirements.

Outlines

00:00

πŸ›‘οΈ Regulatory and Quality Management in Medical Devices

The speaker, a quality manager at Zimmer, introduces the topic of regulatory and quality management for medical devices. They acknowledge the intimidating nature of the subject and the potential costs and efforts involved but emphasize the benefits of a smart system for compliance. The speaker suggests starting early with a quality management system (QMS) to streamline the process of getting medical devices to the market. The Air Force triangle is introduced as a model for balancing quality, cost, and time, aiming for the 'Utopia' of high quality, low cost, and quick time to market. The importance of having a QMS in place from the beginning of product development is highlighted, as it ensures all necessary documentation for regulatory approval is in order, simplifying the process for both the EU and the USA. The speaker also mentions ISO 13485, an international standard for medical device manufacturers, which aligns with the MDR and IVDR regulations.

05:01

πŸ“š Key Components of a Quality Management System

This paragraph delves into the specifics of what constitutes a Quality Management System (QMS) according to ISO 13485. It includes the establishment of a quality policy, a quality manual that outlines the company's processes, an organization chart, and quality goals. The paragraph explains the necessity of a document and record control process to maintain and track all documents produced during the company's operations. It also touches on the importance of defining processes for design and development, including product development plans, risk analysis, and design reviews. The speaker stresses the significance of verification and validation in ensuring the readiness of a medical device for the market. Additionally, the paragraph covers the need for a training program to ensure that team members are adequately prepared for their roles, as mandated by ISO standards.

10:03

πŸ”„ Production and Post-Market Surveillance in Medical Devices

The final paragraph focuses on the production and post-market surveillance aspects of medical device development. It discusses the need for a part numbering system, revision control, and traceability from raw materials to the delivery of the final product. The importance of proper labeling, maintaining stock, and managing expiry dates, especially for chemicals, is emphasized. The paragraph also covers change control processes to ensure that any modifications to the product do not introduce new risks. Purchasing processes, including the evaluation and approval of suppliers, are highlighted as crucial for maintaining product quality. Lastly, the handling of complaints, non-conformities, and feedback from the field are identified as essential processes that need to be documented, reflecting the ongoing commitment to quality after the product has reached the market.

Mindmap

Keywords

πŸ’‘Regulatory Compliance

Regulatory compliance refers to the adherence to rules or regulations relevant to a company's business operations, particularly in the context of medical devices, it means following specific laws and standards to ensure safety and efficacy. In the video, the importance of regulatory compliance is emphasized as a critical aspect of bringing a medical device to market, with compliance to MDR for medical devices and IVDR for in vitro diagnostic devices in the EU, and 21 CFR part 820 for FDA approval in the US.

πŸ’‘Quality Management System (QMS)

A Quality Management System (QMS) is a framework that outlines the processes, procedures, and responsibilities for achieving quality policies and objectives. It is essential for managing and improving the quality of products and services. In the video, the QMS is discussed as a vital tool for medical device manufacturers to streamline their development process and ensure they meet regulatory requirements, with ISO 13485 being a specific standard for the medical device industry.

πŸ’‘ISO 13485

ISO 13485 is an international standard that specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and regulatory requirements. The video explains that adhering to ISO 13485 helps in achieving compliance with various medical device regulations and in establishing a robust QMS.

πŸ’‘Quality Policy

A quality policy is a statement by top management that defines the overall intentions and direction of an organization regarding quality. It's a commitment to quality that is communicated and implemented throughout the organization. In the script, the quality policy is mentioned as a document that outlines the company's view on quality, such as valuing precision and accuracy, and promising high-quality products to customers.

πŸ’‘Quality Manual

A quality manual is a comprehensive document that describes the quality management system of an organization, detailing the processes and procedures that are in place to ensure the consistent production of quality products or services. The video script uses the quality manual as an example of a document that outlines the company's processes, such as procurement, handling customer orders, and dealing with customer complaints.

πŸ’‘Risk Analysis

Risk analysis is the process of evaluating the potential risks that may occur during the development and use of a product, and devising ways to mitigate or manage those risks. In the context of the video, risk analysis is crucial for medical devices as it helps identify and address potential hazards associated with their use, ensuring patient safety and regulatory compliance.

πŸ’‘Design and Development

Design and development refer to the stages of creating a new product or service, from conceptualization to the establishment of detailed specifications and prototypes. In the script, the design and development process for medical devices is discussed, emphasizing the need for a structured approach, including defining specifications, conducting design reviews, and performing verification and validation activities.

πŸ’‘Verification and Validation

Verification and validation are processes used in product development to ensure that the product meets its intended specifications and user needs. Verification confirms that the product complies with specified requirements, while validation ensures that the product fulfills its intended use. The video script mentions these processes as critical steps in the medical device development lifecycle, necessary for regulatory approval.

πŸ’‘Document and Record Control

Document and record control is a process that ensures all documents and records generated during product development and production are properly managed, controlled, and retained. The video emphasizes the importance of this process for maintaining traceability and compliance with regulatory requirements, such as tracking changes and storing records in an organized manner.

πŸ’‘Change Control

Change control is a formal process for evaluating, approving, and implementing changes to a product or process. It ensures that any modifications do not introduce new risks or affect existing ones. In the video, change control is highlighted as a critical process for medical device manufacturers to manage alterations to their products in a controlled and compliant manner.

πŸ’‘Complaints Handling

Complaints handling refers to the process of receiving, documenting, and addressing customer complaints about a product or service. It is an essential part of maintaining quality and customer satisfaction. The video script mentions complaints handling as one of the processes that need to be documented and managed within a QMS, particularly important for medical device companies to ensure they respond appropriately to feedback from the field.

Highlights

The importance of having a quality management system (QMS) in place early in a project to ensure compliance with medical device regulations.

The concept of the Air Force triangle, emphasizing the balance between quality, cost, and time in project management.

The necessity of compliance with MDR for medical devices and IVDR for in vitro diagnostic devices in the EU market.

The requirement of 21 CFR part 820 by the FDA for medical device approval in the US.

ISO 13485 as the international standard for quality management systems specifically tailored for medical device manufacturers.

The components of a QMS including quality policy, quality manual, and organization chart.

The significance of defining quality goals annually and tracking their achievement.

Document and record control processes to maintain and track all documents produced.

The retention period for documents and records as per regulatory and legal requirements.

Design and development processes, including defining a product development plan and milestones.

The importance of risk analysis in medical device development and its role in compliance audits.

The process of verification and validation in ensuring the readiness of a medical device for market entry.

Training programs and their documentation as required by ISO for ensuring team competency.

Traceability in production, from raw materials to customer delivery, as a key aspect of medical device regulation.

Change control processes to manage and assess the impact of any changes made to the product design.

Purchasing processes, including supplier evaluation and approval, as part of the QMS.

Complaints, non-conformity, and feedback handling processes as integral parts of the QMS.

The overarching message that quality in medical device manufacturing is not accidental but a result of intelligent efforts.

Transcripts

play00:00

foreign

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I'm the quality manager here at Zimmer

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and peacock today we will talk about a

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rather intimidating topic it is

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Regulatory and quality some of you might

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think that this is a bit of a difficult

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topic and it will require more time

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effort and money from you to comply with

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the regulation of medical devices

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however I think that you can be smart

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and have a smart system in place that

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will help you get your goal quicker and

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more efficient and get even better

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products so how can we do that that's

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what we'll talk about in this video so

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without further Ado let's start

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first let's talk about the famous Air

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Force triangle for a project where you

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see the relationship between quality

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cost and time so you want to stay in the

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Utopia area where you have the highest

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quality of a product in the shortest

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amount of time and with the lower cost

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possible so how can we stay in this

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Utopia I suggest that you start with

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having a quality manager system in place

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early on in Project as early as possible

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which will help you get into the market

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much quicker

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so I suggest that you start with a

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quality management system from scratch

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where it follows you through your r d

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process all your development stages

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until you have a final product that's

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ready to be put in the market when you

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do that then you will have all the

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documentation required by the

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regulations and the authorities to get

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your device approved in the EU or in the

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USA quite easy and quite straightforward

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and without too much time so let's just

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start with having an idea what do you

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need to get into the market for example

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in the EU to place a new medical devices

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on the market you will need to comply

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with an MDR if it's a medical device or

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an ivgr for in vitro diagnostic device

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so those regulations you really need to

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comply with to be able to send your

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product in the market in the EU for the

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US you have 21 CFR part 820 for the FDA

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approver of your medical devices so okay

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all those regulations always requires

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that you have a quality management

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system and we call it qms in place to be

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able to manage your products what is a

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quality management system a quality

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manager system is in general

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um

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an overall system of how your

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organization or your company is actually

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working

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for medical devices there is an

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international standard called ISO 13485

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that's specifically built for medical

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device manufacturers and developers and

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distributors

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that will that are an adaptation of the

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MDR and ivdr and I and the FTE

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regulations so it will help you become

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in compliance quicker okay now we will

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dive a little bit deeper into iso13485

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what does it mean how do you put it in

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place

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and later on maybe in the next video we

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can talk more about the actual

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regulations of ndri vdr so that you have

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more information about that

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so quality management system according

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to ISO 13485 consists of some documents

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that describe your company in general or

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your organization

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for example you need something called

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the quality policy and a quality policy

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is just one piece of paper describing

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what is your view of quality in your

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organization like for example you value

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quality and precision and accuracy you

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promise your customers a high quality

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High Performance Products something

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general that top management need to sit

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down and discuss and Define that's

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simple to do

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something else is a quality manual and

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within the quality manual you describe

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your different processes in your

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organization for example your company is

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only working in production

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so you will Define all the process in

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relation to this production for example

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how do you do procurement how do you

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handle your customer orders how do you

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handle complaints from your customers so

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you need to Define what actually you are

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doing and put it in the quality manual

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it's like a summary of your your company

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and then you need to have an

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organization chart which is something

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quite easy if you are a small company a

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startup then you like everyone is

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wearing multiple hats doing different

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things so you just Define okay I have

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this person and this person this person

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and those are their assigned roles

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it can be even flexible and it can be

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um less rigid

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you also need quality goals that you

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define for yourself and your company

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each year and then you follow up did you

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actually meet those quality goals or not

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for example you want to improve the

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rates of the yield of your of your

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products you want to reduce the number

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of complaints that you are having from

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one year to the other those are your

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quality goals that you need to Define

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every year

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then we move a little bit into the

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second level which are the different

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processes and the details of how you do

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those processes one of the things that

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you need to have in place is a document

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and record Control process which means

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that every document that you produce

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during your production during your

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design and development during your

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day-to-day activities every document

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need to be well maintained well

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controlled if you do changes those

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changes are tracked and those records

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are stored in a proper place it's easy

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to find you need to identify it properly

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so you have a document IDs

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um how you do this ISO doesn't tell you

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how to do this but it tells you that you

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need to have it you have to have it in

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order to be compliant with ISO 1345 okay

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so this is document and record control

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also of course the retention period how

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long do you have to keep some records

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and some documents and this is also um

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related to some authorities requirements

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and some laws that you have to keep some

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documents like for example chemicals

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um handling or records of how you have

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been your employees were exposed to

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different chemicals those need to be

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maintained for 50 years or something

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like that so you need to have a process

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around it second thing is how do you do

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design and development if you are doing

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this annivers for a new medical device

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then you need to Define your process how

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do you do it how do you assign the team

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do you have a product development plan

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where you say okay for this Pro products

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for example I am going to develop this

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product over the course of 18 months

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within those 18 months you need to

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Define Milestones where you stop and you

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look back and you see okay how good is

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my product now how good is my prototype

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now did I reach all my different

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goals within this Milestone or not so

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this is a product development plan and

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we can dive deeper but now for the time

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we just keep it simple

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you need also to Define specifications

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for your products that you are

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developing you need to consider user

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needs and stakeholder requirements and

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then link it into a specification lists

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that your team will work against and

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make sure that you reach those

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specifications

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of course for medical device something

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very important is risk analysis so you

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need to see how your product will be

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handled in the markets and what risk can

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arise from handling your product so a

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risk analysis activity is very very wide

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very important place where all Auditors

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will audit you on so we can dive deeper

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into that but not today risk analysis is

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something that you need to to consider

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design reviews where you need to as I

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told you sit down with your team and see

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where you are

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um the different Milestones that you

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have to meet during your projects will

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require

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a following certain steps you define you

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specify you implement and then you

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verify and validate verification

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validation is a very important step in

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medical devices where you need to freeze

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your design and then do a verification a

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set of verification tests and the

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validation by clinical studies and then

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you can say okay my device is now ready

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for design transfer and scaling up all

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of those parts are parts of technical

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files that you need for Regulatory

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Compliance moving on to a different

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process for example confidence and

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training contestant training is

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important for you to Define how do you

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train your team

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how do you make sure that they have

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enough contents to do the role that they

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are assigned to do and this is also

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required by ISO so you need to sit down

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and Define what type of training are you

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giving them what type of contents do you

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have for each role so you have something

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called a role description and then you

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have a training program and you have

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records that the training actually

play09:45

happened

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moving on to production so you need if

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you're going to do a production for your

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medical device in the future you need to

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Define how are you doing this production

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so you need to have part numbering

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system you need to have a kind of a

play10:00

revision control of your different parts

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when you actually perform production for

play10:06

a batch you need to have travel forms

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you need to have traceability between

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the raw materials that you use to

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produce this patch up until you actually

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deliver this batch to a customer so this

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whole traceability thing is I mean main

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process in medical device development

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and in production where MDR and ivdr

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will require you to trace back each

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single product you put on the market to

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its raw material and how did you produce

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it so travel forms work instructions

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incoming inspection inspection reports

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outgoing quality control reports

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labeling proper labeling of the device

play10:40

is really really important and it's also

play10:42

controlled by MDR and ivdr also of

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course maintaining your stock making

play10:46

sure that the expiry dates of chemicals

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if you're using chemicals or other

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materials that have expiry dates and

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those are all parts of your production

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process and you need to document how

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you're doing this

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um another part is change control so

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Change Control is really really

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important because this is how you make

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sure that any change you do doesn't

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introduce any new risks or it doesn't

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affect a previous risk so

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um a product a medical device is related

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together so if you do any change to a

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small part that maybe you consider it as

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a small change we don't care about it

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it's something simple but when you sit

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down and do a risk analysis around this

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change you might consider other aspects

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it might affect maybe how you handle

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your data it might affect how the

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results is at the end it might affect

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your suppliers your supply chain so any

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change can any change to a current

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design need to be

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properly hampered so you have a Change

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Control process that you need workload

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another thing is purchasing how do you

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how do you purchase your Euro materials

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how do you evaluate your suppliers those

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suppliers need to be approved and it has

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to be a process how do you how do you

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say that okay this supplier is adequate

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for me to order those materials from

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so that's another process that you need

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to Define and write it down and finally

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you have the complaints uh handling

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non-conformity handling copper handling

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feedback from the field all those

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different processes need also to be

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documented so this was a brief

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description of iso 13485 and please

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remember that quality is never an

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accident it is always the result of

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intelligent efforts thank you so much

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and if you want to support us please

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subscribe to our Channel and if you want

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to know more about the Emirate peacock

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visit our website thank you

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foreign

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