Question
Hello All,Say you're given a product that has passed design validation and is in mass production. The design engineers decide to widen the tolerance of a particular dimension, x.Does this change require design validation?Note: Said differently, the s...
The ISO 13485 standard is being revised and the new version will be released early in 2016. It was originally expected to be released in the fall of 2015 along with the updated ISO 9001 standard, but there were 800 comments on the DIS2 draft and a fi...
Jennifer Register, MBA, RAC
Director of Regulatory Affairs at Secure BioMed Evaluations
December 2015
source: https://www.linkedin.com/groups/2070960/2070960-6080433691904008196
One of my clients sent me an email this morning asking, which upcoming regulatory changes will affect the Declaration of Conformity (DoC) for CE Marking of medical devices. They also requested a link to the new EU legislations which will come into fo...
Former $MELA CEO Dr. Joseph Gulfo's book "Innovation Breakdown" is so enlightening (and well-written) that I invited him to join the 10x faculty in May. Was his experience extreme, biased, or common? BACKGROUND • Each year, 150,000+ Americans are dia...
This topic was submitted to my suggestion box from a colleague in Australia. For brevity sake, I’ll limit my comments here to ISO certification body auditors and exclude FDA inspectors. The basic approach is the same, but there are some important nua...
I have been researching online for some information regarding clean rooms. I do perform some work on what I think is a ISO class 7 or less. Linear flow, HEPA filter etc.What I wonder, is what is a "ISO Class 9", considering that air conditions are eq...
Brian O'Connell BSc MSc 6ΣGB-13 Plus experience
Senior Consultant at KPC International
November 2015
All, A Big Trend I notice in the Pharmaceutical & Biopharmaceutical Industry is the growing importance of Data Integrity. What is the consensus of the group of the focus of the FDA & other Regulatory agencies on Data Integrity for Medical Dev...
ISO 14971 is under systematic review. This means that Nationals Committees will vote if the standard will be reconfirmed, revised, or withdrawn. If you have any comments the use of the standard and suggestions for modifications, I would urge to parti...
With the changes in ISO13485 authorizing notified bodies to perform unannounced audits at what you have identified, or the NB believes, to be critical elements in the value chain. What a boon to NB’s they get to charge us for the cost of audits at ou...
