Insights on risk management topics and tips and techniques for implementation.

Coming Soon - ISO 14971:2019 Harmonization in the EU interactive q&a iso 14971 risk management Sep 27, 2021

According to the latest news, a final draft of the ZA and ZB annexes for harmonization of ISO 14971:2019 is currently going through the voting process

ISO 14971, the International Standard for...

Continue Reading...
Evaluating Benefit-Risk of Medical Devices benefit-risk fda medical device risk management Sep 15, 2021

Evaluating benefit-risk of a medical device is no easy task because it involves making a decision about their safety and effectiveness with very limited information. 

There is no doubt that...

Continue Reading...
1 2 3


Say yes to receiving a practical risk management tip each week!


You're safe with me. I'll never spam you or sell your contact info.