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Like many of you, I have been slogging through the Practical Guide to ISO 13485:2016 since it came out end of September. To be honest I found it anything but practical. The guidance is a behemoth at 214 pages, contains circular references with vague ...
The most common way to answer this question is with a question.How long is a review supposed to take? orHow long does a review actually take?Most people want to know the answer to the second question, and they want real data to back it up. Therefore,...
Earlier today I received the following question via LinkedIn: For verification and validation test records, are signatures needed?The person that asked the question thought the answer should be “Yes,” but is it required?This person read through the F...
Principal at Meader Consulting, LLC
Hi All,Have you noticed some confusion out there in the use of the terms verification and validation as it relates to medical device software? It seems that some say that validation is the actual testing and verification is all of the other activitie...
Diabnext Regulatory Affairs Specialist
I'm now dealing with 510k, but can not understand from FDA website...From the "Deciding When to Submit a 510(k) for a Change to an Existing Device" in FDA website, it states "documentation" as document your analysis and file it for future reference. ...
QA Team Leader at Blatchford
It has now been some time since the release of the updates ISO 9001 and ISO 13485. There was some discussion in this group about how many medical device manufacturers maintain both ISO 9001:2008 and ISO 13485:2003 certification.It would be really goo...
Hyemi Shin (신혜미,차장)
Principal Quality Systems Specialist at Medtronic Korea
Hello, i'm working in spinal implant manufacturing company. DHF formalises input, output, verification, validation, review and transfer. After post production we continue to create revised DHF for design changes. Our DHF is system based e.g. Cervical...
Chief Quality Officer
Hi everybody! Can someone tell the difference between the sentences: 1- " shall document a procedure" and 2- "shall document procedures"? Does 1 mean that we need to implement one procedure per subject ( internal audit, control of documents..) and 2 ...
Most regulatory experts work on medical device OR in vitro diagnostics--not both. Making the switch from one type of 510(k) to another is not that hard.First, the submission content and format requirements are the same. There are still 20 sections, a...
Senior Quality Engineer/Medical Devices/CSSBB
As per process validation definition in ISO-13485 and FDA CFR 21 Part 820 I have a concern where help from groups members is really appreciated,Recently I read a procedure that states that, since regular lots size are too big, sampling can be conduct...