Risk management for medical devices and ISO 14971 - Online introductory course

This is an online short course on Risk Management for Medical Devices and ISO 14971:2019. It also includes a comparison between ISO 14971 risk management and FMEA.

The course is great for onboarding employees, and the participant will receive a course certificate upon completion.

Starting October 2023, the templates mentioned in the video are no longer available for free on Medical Device HQ. However, more comprehensive paid versions are now accessible via this link:

We offer premium templates for free to our newsletter subscribers. Instant access to some templates is granted upon subscription. Others will be distributed periodically as part of our newsletter email campaigns.

Chapters
00:00 About the instructor
00:24 Introduction to this short course
00:41 Learning goals of this short course
01:14 Implementing an ISO 14971 risk management process
01:31 Creating a safe medical device
02:01 The ISO 14971 definition of safety
02:53 What is risk management for medical devices?
03:23 An overview of the risk management process
04:17 Risk management is a requirement in the US and the EU
05:03 The risk management process from start to end
07:18 The ISO 14971 definition of risk
07:31 Estimating the probability of occurrence of harm (Po)
08:36 Risk control options analysis
08:58 Risk control measures
09:21 Verification of effectiveness
10:03 Implementation of risk controls
10:28 Estimating the residual risk
11:16 Risk management review and the risk management file
12:39 Production and post-production activities
13:54 An overview of the FMEA
14:30 ISO 14971 risk management vs. IEC 60812 FMEA
16:16 Additional help and resources

[eleazarmabe]

Thanks, your presentation was very informative. (Juarez, Mexico)

[margarettuvelle]

This was really great! Very informative and short. I have sent it to several colleagues.

[premasubramanian]

Your presentation and explanations are very clear, easy to understand...and my doubts were cleared . Thank you sir,

[bujji.kbujjiprem]

Such a clear and great explanation 👏 👏 ...Thank you so much ❤

[mohamedhabas]

Love the risk management concept in medical industry

[thimmareddy]

It's an informative session. I have a query regarding RPN, why we are not considering the detection measures in risk evaluation

[ThalariTeju]

Thanks for the forecast! I have a quick question: I have a SafePal wallet with USDT, and I have the seed phrase. (behave today finger ski upon boy assault summer exhaust beauty stereo over). What's the best way to send them to Binance?

[jhannheras]

Great content! I am doing a risk management plan and this is perfect.

[poornanandans]

Very informative & learnt the link between DFMEA & RMF.... Thanks a lot🙏

[carawilcox]

Peter, your videos are fabulous. I love your style.

[mohanbhatsingapore]

I really loved this crystal clear precise Presentation. A lot to learn. Thank you Sir

[maikonronsaniborges]

Congrats! Your video is very clear and straight to the point!

[riyagupta]

Could you please give an example of normal use risk to understand more clearly about the difference in FMEA and ISO 14971

[sn]

Hello! I have a writing test for an interview. I have no experience in medical writing. They want me to write a risk-benefit-analysis and provided me with articles.

I would really appreciate it if you can tell me how can I do that? And do I need statistical analysis?

[misame]

Thanks for all the explanation, it was very clear and helpfull.

[Mueen]

Thank you. Very informative and organized !

[chrismallett]

How is the traditional Process FMEA addressed by the Hazard Traceability Matrix, with respect to ensuring each process step in the manufacturing process has its risk of manufacturing a product out of specification correctly assessed ?
Can the same Hazard Traceability Matrix be used for PFMEA as described in the video ? would the headers be slightly different to capture PFMEA risk ?
Do you have a template available ?
Can the Same Hazard Traceability Matrix be used to replace an existing Design FMEA ? would the header be slightly different to capture DFMEA risk ?
Best Regards, Chris.

[Ken]

The presenter showing FMEA as a separate tool from ISO14971. Many companies reliably use FMEA as one of the elements of RM to meet 14971. The FMEA is adopted to cover risk identification, quantification and evaluation. Also there are different types of FMEA’s and some do cover the Risks associated with the normal use of the product ( I.e. use-FMEA). In addition, FMEA are beneficial in the development of control plans and identifying Essential Design Outputs. The point is that FMEA’s has advantages other tools do not.

[johnnybravo]

A FMEA is not a risk assessment. It is a method to ensure quality.

[kitsadatanerat]

If​ risk​ evaluation​ ALARP​ need​ ​ reduce to​ ACC​ only​ or not? Please advise