Training as well as certifications for ISO 13485:2016, 21 CFR 820...

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anonymous16

Hello! :bigwave:

Does any of you know of a reliable place or online source that will provide training as well as certifications for ISO 13485/FDA QSR? It's been a while since I worked with medical devices... for the past 10 years I've been working with Pharma and Nutraceuticals... having started a new position with medical devices I'd like to get a refresher.

Thanks in advance.
 

Ronen E

Problem Solver
Moderator
Also have a look at CDRH Learn.

Not sure what you mean by “online certifications”, but in general you should be suspicious about it.
 

Jane's

Involved In Discussions
Also have a look at CDRH Learn.

Not sure what you mean by “online certifications”, but in general you should be suspicious about it.
The way I understand the OP question, online certification is taking an assessment online which successful completion (passing score) earns you a certificate which states that you have passed the assessment.

If the above is correct, and if that was your assumption too, I am not sure why the recommendation to be generally suspicious about it (suspicious about the institution, the assessment, or the person offering an online certification as their proof of qualification)?
 

Ronen E

Problem Solver
Moderator
The way I understand the OP question, online certification is taking an assessment online which successful completion (passing score) earns you a certificate which states that you have passed the assessment.

How is the identity of the person actually completing the assessment verified?
 
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