Medical Device Directive - Anyone know of any good MDD training courses

Q

qagirl

Thanks for the info about webinars. I am wondering if they are in-depth enough.
I will check out the BSI webinar web-site. Maybe it's enough to get going, and then take another course later.
 
R

rose24m03

registrar assessment audits

Depends on the auditors assigned to audit your organization, you get various results from the same registrars (even the one you mentioned here). All I can say is that most of the time registrar auditors only scratch the top layer of issues. Let's just say that you would be very amazed with number of issues I found in internal audits when compared to what our notified body found in their surveillance audits. For areas they said we have no issues we ended up getting major issues from FDA inspectors. :eek:

Same can be said with those 5-day lead auditor classes. So far, I found that Martha from Excel Partnership taught the best class. Money was well spent in summer 2002. To create a pool of part time auditors, our company subsequently had used both ASQ and BSI last year for 13485 lead auditor and 14001 internal auditor training courses at our site. In my opinion, it was a waste of money and time to read the standard in classes. People didn't get a chance to fully practice identifying nonconformances, writing nonconformance statements, conducting opening and closing meetings with feedback from instructors.
 
Top Bottom