Question
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...
There are 11 different types of software validation documents that the FDA requires. One of the documents is a rationale for the "Level of Concern." Level of Concern (LOC) is a term that the FDA uses to categorize the risk of software as a medical de...
Most countries have some kind of database for gathering adverse event data for medical devices, but most of these databases are not open to the public. The most common question I am asked is, “How do you access the Eudamed database?” for reporting of...
Sabrina Dessources
Senior Manager Regulatory Affairs-CMC at Alexion Pharmaceuticals, Inc.
August 2015
Good morning everyone, I need some advice please! Hopefully someone can shed some light! The company manufactures IVD devices, and the QMS is currently in conformity with BS EN ISO 13485 (and all other applicable EN ISO Standards). Because we will al...
Hi all. does anybody know how one can find out which NBs have already been accredited? I know BSI have, they naturally boasted being the first ones. but is there some list or do I have to screen the NANDO? source: https://www.linkedin.com/groups/2070...
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...
What is considered best practice for assessing effectiveness of change control actions within the QMS? I am wondering if a CC file remains open during this period or whether it is closed at execution and then tracked separately, e.g. as a CAPA. Alter...
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...
Those wonderful devices you made, perfectly calibrated when customers opened the box, are still your responsibility once deployed.This guest post, courtesy of Gregg Schaeppi, Director of Client Services for PK Calibration & Validation, taught me ever...
If you ask “how much less documentation is required for the design of a Class 1 device compared with a Class 2 device?” you get a very different answer. Instead of 0% (Yes a DHF is required) of 100% (No DHF required), the answer is that you need 33% ...