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

[anonymous16]

Hello!

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.

 

[Jane's]

Hi anon, I would check BSI for online training, here is the page: Quality Management Training Solutions from BSI

Depending on where you are, you may want to look into MDSAP training and kill two birds with one stone.

 

[Ronen E]

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]

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]

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?

 

[Jane's]

That makes sense, thanks.