The Importance of IEC 62304 Compliance

August 15, 2018

Read More ›

Don’t be a ”victim” of your Quality System, but instead use it to achieve your objectives!

June 18, 2018

Read More ›

What is a Risk Mitigation Requirement and How to Write It?

May 22, 2018

Read More ›

What is Probability of Failure of Medical Device Software?

April 24, 2018

Read More ›

Risk Management for JIRA. Why?

September 22, 2017

Read More ›

FME(C)A or FMEA?

June 29, 2017

Read More ›

What is a Risk/Benefit Analysis & How To Do It?

May 12, 2017

Read More ›

What is FMEA and how is it different from Hazard Analysis?

March 30, 2017

Read More ›

New Medical Devices Regulation & Risk Management

March 15, 2017

Read More ›

What is FMEA and when to use RPN?

March 13, 2017

Read More ›