Question
I have received a request regarding legalization of documents that I could use some guidance on. The request originates from Mexico, asking that an ISO cert for an OEM be legalized either 1) in the originating country of the certificate issuer or 2) ...
The best regulatory affairs managers review guidance documents and quickly identify which elements are most important and will require the most amount of time. These elements are prioritized first for a regulatory submission project.In last week’s bl...
Companies developing devices with truly innovative technologies frequently have difficulty identifying suitable predicate devices. The best regulatory experts plan in advance for these regulatory submissions by honing their knowledge of the De Novo a...
source: https://www.linkedin.com/groups/2070960/2070960-6095219699472220163
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...
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...
