Thank you, all, for your feedback. If I make any updates to the flowchart I will post it in this thread.
Rob, thanks for the input.
My reasons for showing the "unadulterated" (EN) ISO 14971:2019 requirements versus the additional MDR requirements are:
1. Purely academic interest, trying to get into the brains of the framers of 14971 and the MDR.
Is the MDR more or less "state-of-the-art" as compared to 14971:2019? Where is this train headed?
2. Many/most of the U.S. based startups I am working with are only focused on U.S. marketing efforts (and solely ISO 14971) because:
(a) that is where they live, making it easier to support U.S. customers;
(b) the Europe MDR requirements are viewed as more-burdensome as compared to U.S. FDA requirements; and
(c) their funders (angels, VCs, etc.) are advising against Europe until after exiting (i.e. "let the acquiring company deal with Europe and the rest of the world").
Having said that, there is a lot of wisdom in weaving the MDR into the firm's quality system fabric, but making allowances for not implementing all MDR requirements with the understanding that no devices will be marketed in Europe until those requirements are met.
Sam Lazzara
Medical Device Quality Consultant
San Francisco Bay Area, California USA
https://mdqc.blog------------------------------
Original Message:
Sent: 17-Feb-2020 09:45
From: Rob Packard
Subject: Device risk management flowchart (EN ISO 14971:2019 and MDR)
Hi Sam,
I took a look. :)
It looks very thorough, and I don't see anything left out. I certainly think that the ISO/TR 24971 guidance is helpful in explaining how some of the steps in your flow chart should be done. In particular, the creation of a risk acceptability policy. It will be important for anyone that is developing a CE Marked product to have a policy that clearly considers both the relevant harmonized standards, common specifications, and the state of the art.
A detailed work instruction, template or training for the benefit/risk analysis is needed too.
The only part of your approach I'm not fond of is the option for two different processes: 1) with MDR, and 2) without MDR. I would prefer to have a single process for all products. I believe the MDR process is more stringent and therefore just complying with the MDR process should satisfy any other markets.
------------------------------
Rob Packard
Shrewsbury VT
United States
Original Message:
Sent: 11-Feb-2020 13:07
From: Sam Lazzara
Subject: Device risk management flowchart (EN ISO 14971:2019 and MDR)
I took a stab at creating a single flowchart that points out differences between the 2019 standard and the MDR.
This is just a starting point for me. If anyone has any input that I like/agree with (smile) I will surely update it.
Here is a link to my flowchart. This link should work in the future even if I have made updates.
https://mdqc.com/iso-149712019-europe-mdr-risk-management-process-flow/
Here is a link to my prior flowchart focused on EN ISO 14971:2012 versus the Europe MDD.
Note: I created the new chart using LucidChart and would be happy to share the native files if there is any interest. You will probably need a LucidChart account for the files to be useful. I am not affiliated with LucidChart in any way other than being a happy customer. Please send an email to sam@mdqc.com to request LucidChart link.
------------------------------
Sam Lazzara
https://mdqc.blog
------------------------------