Medical Device Directive - Seeking common nonconformance write up scenarios

MCG104

Registered
As a new auditor for a NB, I have survived my first 6 months of ISO13485 and 9001 independent audits so far. I have a good background working with a variety of products but a very limited background in auditing. Now I'm being directed to learn the MDD and to take an assessor exam on it in order to conduct CE Mark assessments. I've been hinted to that the exam has a written portion that gives CE Mark assessment scenarios in which I would have to write out how I would handle the scenarios. I can handle fill in the blank type of test but due to my limited time as an assessor I am seeking any common CE Mark auditing scenarios, I can get from any experienced and versed auditors out there. Specifically explaining if the scenarios resulted in a major or a minor and what it was written up against to help me get a better understanding for skills verses memorizing guidelines. Or if anyone knows of any MDD test your knowledge type of resources (example: practice questions) please share. Thanks!
 

Ronen E

Problem Solver
Moderator
This sound like a strange practice on the NB's part. I would have expected them to team you up with some senior/seasoned MDD auditor for a while, where you'd have had a chance to experience such scenarios first hand. Sort of an apprenticeship, where you initially just observe, then you get to do simple chores, them more and more complicated ones, until you're ready to go on you own. Only then I would have expected formal testing and certification.
Maybe they're hurrying things up because the MDD will be obsolete soon...?
 

Watchcat

Trusted Information Resource
Or maybe all of their senior MDD auditors are being trained and deployed on MDR work as fast as they can be?
 
Top Bottom