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Special Offer

Confused about exactly what documentation is needed in your risk management file for ISO 14971 compliance?

Grab this mini-course for only $21 USD!

You will get:

1. Video lesson on ISO 14971 requirements for the risk management file

2. Detailed checklist of documentation requirements in each sub-clause

3. A simple and compliant documentation structure for your risk management file

4. Bonus video - audit-preparation tips for your next risk management system audit!

 

Hazard Analysis Workshop

A 3h LIVE workshop to help you gain practical knowledge of medical device hazard analysis

What you'll get:

  • Pre-recorded video to help you prepare for the LIVE workshop
  • Extensive slides and notes
  • A template for hazard analysis
  • Hands-on experience in hazard analysis during the LIVE workshop
  • Certificate of competence in Hazard Analysis 

Note: you must select one of the upcoming workshop sessions to reserve your spot. You will be able to make your selection after completing the checkout. 

What People Are Saying:

I attended the 3-hr workshop on Preliminary Hazard Analysis(PHA) by Naveen Agarwal, Ph.D. Great tool for medical product risk planning early-on, even at proof of concept stage and ensure ISO14971 compliance. Naveen guided through the process of PHA and how it links to the traceability matrix using a comprehensive PHA template and real world exercises. Presentation slides provided are extremely useful and PHA Template hand out can be used as is or adapted easily. I highly recommend his training sessions for medical device professionals in quality, regulatory, clinical, and R&D functions.

Vinay B.