3-Hour Workshop: Are You Afraid of the Three New Risk Requirements for 2020?

You already have a risk management procedure, and you already have risk management training, but do you know how to update your training and procedures for all three of the new risk management requirements?

Yes, there are three:
ISO 14971:2019 – December 16, 2019 (49 pages)
ISO/TR 24971:2020 – February 2, 2020 (100 pages)
EU MDR Annex 1 – May 26, 2020 (Sections 1-9)

The last time we had a major change in risk management requirements was in 2012. EN ISO 14971:2012 was published, and everyone learned the hard way about the 7 deviations. Nearly 100% of device companies received a non-conformity related risk management due to one of those 7 deviations. This year, instead of one standard change, there are three changes.

You can read the 150 pages of new material, identify gaps in your procedure, edit your procedure, and create a training for every design engineer in your company. Then you can start to update all of your risk management files for the FDA and CE Marking.

We revised our risk management procedure twice, updated our risk management training webinar, and we’re hosting a new webinar on February 10, 2020. If you need help with a plan to update your risk management files, you could also attend our 3-hour workshop at Joe Hage’s 10x Medical Device Conference in San Diego on April 14.

The workshop will have 3 parts. Rob Packard will explain what changed in Part 1. Mary Vater will explain the impact of these changes on your software development documentation. During Part 3, we will open the workshop to an extra long Q&A session to answer your specific questions.

You might be curious why we are devoting one-third of the workshop to software development. EN ISO 14971:2012 only used the word “software” once in the body of the standard, and 13 times in the annexes; while ISO 14971:2019 uses the word “software” 8 times, and ISO/TR 24971:2020 uses the word “software” 46 times. There is more emphasis on the application of risk management, because integrating devices with software applications is the single biggest trend in our industry. We also know that documenting software risk management is your weakness.