Question
Hello,How would you classify fibrin-glue like medical device? The intended purpose of the device is management of bleeding in traumas or surgical procedures (i.e endoscopy) IIb or III and why?
I have a question on MDR implementation: Is it confirmed that custom-made devices are exempt from CE marking?According to MDR art.20 par.1, and art.52 par.8, I believe that custom-made devices are exempt from CE marking. Are there any conflicting int...
First, I have to say how liberating it is to be writing you on my own site versus LinkedIn. I literally feel a wave of relief washing over me. First, I don't have to count characters. Second, I've already used italics(!), something LinkedIn doesn't ...
A subscriber (Irina) asks, "The TSE Risk estimation document (Germany, 1994), "Safety Requirements for Medical Products Derived from Body Constituents of Cattle, Sheep, or Goats to Avoid Risk of Transmission of BSE or Scrapie," requires an estimate o...
From the looks of things, pretty big. If you tuned into the first of FDA’s Case for Quality webinars, you learned about FDA’s shift their from 'compliance with regulations' to 'device quality.' Get the replay and register for part two at https://medg...
The DIS (Draft International Standard) of the review of ISO 14971 - Health Product Risk Management - should be circulated to national committees soon. The ballot will remain open until mid-October.It is extremely important for those involved to revie...
I am looking for a cloud-based Quality management system with at minimum Document change management and Design control features. Any recommendations? source: https://www.linkedin.com/groups/78665/78665-6422825542688477185
Ooh, I've got a good one for you today: An FDA regulator is giving a special 90-minute webinar for Greenlight Guru and the Medical Devices Group. Shout out to Jon Speer for arranging. Your free registration at https://medgroup.biz/case-quality. Franc...
Bradley Merrill Thompson, RAC
Medical Device, Digital Health and Combination Product Regulatory Attorney
June 2018
FDA updates Pre-Cert program as it begins to grapple with ‘hard questions’New updates to the FDA's Software Pre-Cert working model shows the program is making significant gains, but FDA attorney Bradley Merrill Thompson tells FierceHealthcare the age...
One of the themes I come across regularly with my medical product manufacturing clients is uneven skills in investigation and determining root cause through a rigorous and adequate Root Cause Analysis (RCA). In some cases, it is newer team members wh...
