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작성자쌍둥이 조회 4회 작성일 2020-11-25 16:17:24 댓글 0



ISO 13485:2016 for medical device - Overview presentation.
Full course at:

Best ISO 13485:2016 Starter Video [For Medical Devices]

Easy Medical Device - is a blog to learn about the Medical Device Regulations and Standards.

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On this video, I will tell you what is ISO 13485 version 2016
Where does it come from?
Who can certify you for this standard?
What are in the main chapters?

It´s really important for the medical device industry to have a better understanding of this standard as it is one of the famous ones.

It was issued in 2016 and the transition period is 3 years. So you should be finished with your transition by March 2019.

This standard is also included on the MDSAP program so if you want to sell your product in CANADA, ISO 13485:2016 is an obligation. (Check this article: and also the video on my channel about MDSAP)

Even FDA said that they are now thinking to transition the QSR to the ISO 13485:2016 so this will become a major standard for the Medical Device Community.

Let´s see what is included inside.

ISO 13485 has 5 chapters that you´ll need to understand:
- Chapter 4: Quality Management System
- Chapter 5: Management Responsibility
- Chapter 6: Resource management
- Chapter 7: Production Realization
- Chapter 8: Measurement, Analysis, and Improvement

If you are interested to know more about ISO 13485, you can also check my article on BEST TIPS FOR ISO 13485:2016 (

Please provide me your questions that I can include in this article. I will include my answer to it.

Links from the Video

- FAQ 13845:2016 (Provide your questions) -
- Check for accredited companies for ISO 13485:2016 -
- How to prepare for an audit -
- Podcast Episode 5: Medical Device Prediction 2019 -
- Person Responsible for Regulatory Compliance -
- Free Mini-Course MDR 2017/745 -
- ISO 13485:2016 Affiliate link:

Social Media to follow


#medtech #medicaldevice #compliance

Link to this Video:

What is ISO 13485 for medical devices?

A brief introduction to this ISO Standard for medical devices. ISO 13485:2016




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