ISO 14971 - Looking for Advanced Level Training/ Seminars •

[Pola]

Hello everyone,

I’m looking for recommendations for advanced-level training or seminars on ISO 14971:2019, ideally designed for professionals who already have a solid understanding of risk management principles but want to deepen their knowledge and learn how to integrate it with regulatory frameworks such as EU MDR and FDA requirements.

I’m particularly interested in programs that:

• Go beyond the basics and address practical implementation of risk management within a regulatory context
• Cover alignment with ISO/TR 24971, MDR, and FDA, etc
• Offer case studies or workshops related to medical device technical documentation

If anyone has attended a valuable course, webinar, or in-person seminar (e.g., through RAPS, TÜV, BSI, NSF, or other organizations), I’d really appreciate your recommendations and feedback.
Thank you in advance for your insights!

 

[d_addams]

This doesn't directly answer your question since it is not a specific course, but I'd recommend
1- get Safety Risk Management for Medical Devices (Bijan Elahi). Read it all, then read it again.
2 - attend the 2026 Int. MedTech Safety Conference (IMSC26) HOME | International Confer. There are offline attendance options as well, but you'll get much more out of attending in person. The conference has a great community of people discussing the topics you are looking to learn more about.

One of the major challenges in the practice of Risk Management is there is no one size fits all approach. Many times RM systems are set up to manage a very specific therapy so the system is not necessarily robust for use with another therapy (which you may encounter when you switch companies) or the system is very generic to address the many therapies in the company so there isn't much specificity on how to handle certain situations which doesn't help developing individuals.

All of this contributes to variable implementation and execution which is not directly translatable to all situations causing practitioners to be confused and uncertain how to address a situation. Even if you take a course, you'll be at the mercy of how that teacher believes 'its should be done'. A specific example is 'must a medical device have essential performance', there are camps that say 'obviously yes' and others that say 'obviously no'. (obviously yes is the correct answer )

I wouldn't discourage you from taking a course, but continue to read the standard, the TR, read Bijan's book, and engage in conversations as you think through the process. Identify what steps in your existing policies and procedures link directly to the standard (i.e. where in your policy are you addressing 4.5, 5.1a, 5.3, 7.5, 9, etc.). The more intimate you are with how your policies link to the standard the better off you will be at naming the points of confusion which will lead to better conversations.

 

[Tidge]

I'm not 100% behind the Bijan Elahi recommendation... The simplest criticism is that he overuses the phrase "state of the art"... and in some places I think SOTA is effectively redefined as achieving a fully constrained state-of-knowledge (about whatever) which simply isn't practical ... and in some cases his SOTA approaches break down under scrutiny.

Having shared that (general) criticism, much of the text is fine... just be aware that (to me) the (over)use of SOTA is pretty much a sales pitch... I mean who wouldn't want a "state-of-the-art" risk management process? His BXM approach uncomfortably slides from the 14971 use of SOTA to refer to technology and clinical choices into a personal description of risk management methodologies.