Question
If you have testing data for safety and performance, but the data does not meet the current requirements for a submission, what should you do?For Europe, companies are required to update their technical documentation and retest when appropriate. If t...
As originally asked by Divya G. EU representative for CE marking: is Israel consider an European address in your point of view? Julie Omohundro Principal Consultant at Class Three, LLC Divya, just put your cursor over Stacy's name next to her comment...
Just had an article referred to me about ISO 14971 that we all should read. It was a written by an academic researcher in product safety risk management and discusses the merits of ISO 14971.https://onriskof.com/2016/10/03/medical-device-risk-iso-149...
source: https://www.linkedin.com/groups/2070960/2070960-6200379152344846338
Thank you for your time and congratulations on your involvement in Medical Devices. I am writing because I am considering a shift in career toward medical device manufacturing. My background is management of high-tech/computer manufacturing and test ...
I am interested in learning the best process for acquiring an ISO 13485 Certification. From the research I have, it seems like accredited 3rd parties are the best way to go. However, there does not seem to be much information about the process as a w...
I recently reviewed a sterilization validation protocol for a client and I thought some of you might be interested in the things that needed to be modified:1. Make sure you specify the revision of all standards referenced and make sure the version is...
Hi all,I was wondering what exactly a Qualified Person (QP) in the field of medical devices does and means? According to some sources which I am reading, it says “Manufacturers shall have available within their organization at least one qualified per...
Most likely something discussed in the past and hopefully answered easily. We have been completing our 21 CFR Part 820 compliance and are in really good shape for a contract manufacturer of medical devices. I have been receiving competing information...
This morning I was listening to my favorite daily podcast. The podcast guest made an extremely controversial statement. He said that he no longer agrees with one of the most popular entrepreneurship books called “Lean Start-up.” The book encourages s...
