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

Summary

This 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

• 😀 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.
• 🚀 Starting with a quality management system (QMS) early in the project can expedite market entry and ensure regulatory compliance.
• 📚 A QMS should follow the development stages of a product, ensuring all necessary documentation for regulatory approval is in place.
• 🏥 Compliance with regulations like MDR for medical devices or IVDR for in vitro diagnostic devices is mandatory for EU market entry.
• 🇺🇸 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.
• 📋 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.
• 📝 Document and record control processes are crucial for maintaining and tracking all documents produced throughout the product lifecycle.
• 🔍 Risk analysis is a critical component of the QMS, ensuring that potential risks associated with the product are identified and managed.
• 🛠️ Design reviews, verification, and validation are essential steps in the development of medical devices to ensure they meet specifications and are safe for use.
• 🛡️ Change control processes are vital to ensure that any modifications to the product do not introduce new risks or affect existing ones.
• 🛒 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

🛡️ 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

📚 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

🔄 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.

Keywords

💡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.

💡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.

💡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.

💡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.

💡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.

💡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.

💡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.

💡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.

💡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.

💡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.

💡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

foreign

I'm the quality manager here at Zimmer

and peacock today we will talk about a

rather intimidating topic it is

Regulatory and quality some of you might

think that this is a bit of a difficult

topic and it will require more time

effort and money from you to comply with

the regulation of medical devices

however I think that you can be smart

and have a smart system in place that

will help you get your goal quicker and

more efficient and get even better

products so how can we do that that's

what we'll talk about in this video so

without further Ado let's start

first let's talk about the famous Air

Force triangle for a project where you

see the relationship between quality

cost and time so you want to stay in the

Utopia area where you have the highest

quality of a product in the shortest

amount of time and with the lower cost

possible so how can we stay in this

Utopia I suggest that you start with

having a quality manager system in place

early on in Project as early as possible

which will help you get into the market

much quicker

so I suggest that you start with a

quality management system from scratch

where it follows you through your r d

process all your development stages

until you have a final product that's

ready to be put in the market when you

do that then you will have all the

documentation required by the

regulations and the authorities to get

your device approved in the EU or in the

USA quite easy and quite straightforward

and without too much time so let's just

start with having an idea what do you

need to get into the market for example

in the EU to place a new medical devices

on the market you will need to comply

with an MDR if it's a medical device or

an ivgr for in vitro diagnostic device

so those regulations you really need to

comply with to be able to send your

product in the market in the EU for the

US you have 21 CFR part 820 for the FDA

approver of your medical devices so okay

all those regulations always requires

that you have a quality management

system and we call it qms in place to be

able to manage your products what is a

quality management system a quality

manager system is in general

um

an overall system of how your

organization or your company is actually

working

for medical devices there is an

international standard called ISO 13485

that's specifically built for medical

device manufacturers and developers and

distributors

that will that are an adaptation of the

MDR and ivdr and I and the FTE

regulations so it will help you become

in compliance quicker okay now we will

dive a little bit deeper into iso13485

what does it mean how do you put it in

place

and later on maybe in the next video we

can talk more about the actual

regulations of ndri vdr so that you have

more information about that

so quality management system according

to ISO 13485 consists of some documents

that describe your company in general or

your organization

for example you need something called

the quality policy and a quality policy

is just one piece of paper describing

what is your view of quality in your

organization like for example you value

quality and precision and accuracy you

promise your customers a high quality

High Performance Products something

general that top management need to sit

down and discuss and Define that's

simple to do

something else is a quality manual and

within the quality manual you describe

your different processes in your

organization for example your company is

only working in production

so you will Define all the process in

relation to this production for example

how do you do procurement how do you

handle your customer orders how do you

handle complaints from your customers so

you need to Define what actually you are

doing and put it in the quality manual

it's like a summary of your your company

and then you need to have an

organization chart which is something

quite easy if you are a small company a

startup then you like everyone is

wearing multiple hats doing different

things so you just Define okay I have

this person and this person this person

and those are their assigned roles

it can be even flexible and it can be

um less rigid

you also need quality goals that you

define for yourself and your company

each year and then you follow up did you

actually meet those quality goals or not

for example you want to improve the

rates of the yield of your of your

products you want to reduce the number

of complaints that you are having from

one year to the other those are your

quality goals that you need to Define

every year

then we move a little bit into the

second level which are the different

processes and the details of how you do

those processes one of the things that

you need to have in place is a document

and record Control process which means

that every document that you produce

during your production during your

design and development during your

day-to-day activities every document

need to be well maintained well

controlled if you do changes those

changes are tracked and those records

are stored in a proper place it's easy

to find you need to identify it properly

so you have a document IDs

um how you do this ISO doesn't tell you

how to do this but it tells you that you

need to have it you have to have it in

order to be compliant with ISO 1345 okay

so this is document and record control

also of course the retention period how

long do you have to keep some records

and some documents and this is also um

related to some authorities requirements

and some laws that you have to keep some

documents like for example chemicals

um handling or records of how you have

been your employees were exposed to

different chemicals those need to be

maintained for 50 years or something

like that so you need to have a process

around it second thing is how do you do

design and development if you are doing

this annivers for a new medical device

then you need to Define your process how

do you do it how do you assign the team

do you have a product development plan

where you say okay for this Pro products

for example I am going to develop this

product over the course of 18 months

within those 18 months you need to

Define Milestones where you stop and you

look back and you see okay how good is

my product now how good is my prototype

now did I reach all my different

goals within this Milestone or not so

this is a product development plan and

we can dive deeper but now for the time

we just keep it simple

you need also to Define specifications

for your products that you are

developing you need to consider user

needs and stakeholder requirements and

then link it into a specification lists

that your team will work against and

make sure that you reach those

specifications

of course for medical device something

very important is risk analysis so you

need to see how your product will be

handled in the markets and what risk can

arise from handling your product so a

risk analysis activity is very very wide

very important place where all Auditors

will audit you on so we can dive deeper

into that but not today risk analysis is

something that you need to to consider

design reviews where you need to as I

told you sit down with your team and see

where you are

um the different Milestones that you

have to meet during your projects will

require

a following certain steps you define you

specify you implement and then you

verify and validate verification

validation is a very important step in

medical devices where you need to freeze

your design and then do a verification a

set of verification tests and the

validation by clinical studies and then

you can say okay my device is now ready

for design transfer and scaling up all

of those parts are parts of technical

files that you need for Regulatory

Compliance moving on to a different

process for example confidence and

training contestant training is

important for you to Define how do you

train your team

how do you make sure that they have

enough contents to do the role that they

are assigned to do and this is also

required by ISO so you need to sit down

and Define what type of training are you

giving them what type of contents do you

have for each role so you have something

called a role description and then you

have a training program and you have

records that the training actually

happened

moving on to production so you need if

you're going to do a production for your

medical device in the future you need to

Define how are you doing this production

so you need to have part numbering

system you need to have a kind of a

revision control of your different parts

when you actually perform production for

a batch you need to have travel forms

you need to have traceability between

the raw materials that you use to

produce this patch up until you actually

deliver this batch to a customer so this

whole traceability thing is I mean main

process in medical device development

and in production where MDR and ivdr

will require you to trace back each

single product you put on the market to

its raw material and how did you produce

it so travel forms work instructions

incoming inspection inspection reports

outgoing quality control reports

labeling proper labeling of the device

is really really important and it's also

controlled by MDR and ivdr also of

course maintaining your stock making

sure that the expiry dates of chemicals

if you're using chemicals or other

materials that have expiry dates and

those are all parts of your production

process and you need to document how

you're doing this

um another part is change control so

Change Control is really really

important because this is how you make

sure that any change you do doesn't

introduce any new risks or it doesn't

affect a previous risk so

um a product a medical device is related

together so if you do any change to a

small part that maybe you consider it as

a small change we don't care about it

it's something simple but when you sit

down and do a risk analysis around this

change you might consider other aspects

it might affect maybe how you handle

your data it might affect how the

results is at the end it might affect

your suppliers your supply chain so any

change can any change to a current

design need to be

properly hampered so you have a Change

Control process that you need workload

another thing is purchasing how do you

how do you purchase your Euro materials

how do you evaluate your suppliers those

suppliers need to be approved and it has

to be a process how do you how do you

say that okay this supplier is adequate

for me to order those materials from

so that's another process that you need

to Define and write it down and finally

you have the complaints uh handling

non-conformity handling copper handling

feedback from the field all those

different processes need also to be

documented so this was a brief

description of iso 13485 and please

remember that quality is never an

accident it is always the result of

intelligent efforts thank you so much

and if you want to support us please

subscribe to our Channel and if you want

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visit our website thank you

foreign