After a one-year delay due to the COVID-19 pandemic, the Medical Device Regulation (MDR)...
Recently, Mark Horn, Director at The FlexPro Group, had the opportunity to interview Dr. Tammy...
EMERGENCY USE AUTHORIZATION AND ENFORCEMENT FDA RESPONSE TO COVID-19 – INFUSION PUMPS &...
EMERGENCY USE AUTHORIZATION AND ENFORCEMENT FDA RESPONSE TO COVID-19 – DIAGNOSTIC TESTING In...
EMERGENCY USE AUTHORIZATION AND ENFORCEMENT FDA RESPONSE TO COVID-19 – RECOMMENDED SUBMISSION...
DID YOU KNOW? the MDR allows for a Technical Equivalence with a similar design rather than the same...
AGING YOUR TEST SAMPLES DOESN’T MEAN IT HAS TO AGE YOU Stability testing is one of the components...
QUESTION 1 HAVE YOU IDENTIFIED YOUR LABEL CONTENT? Invent your label one time. The need for a new...
The FDA requires demonstration that a medical device sterile barrier system (SBS) will maintain its...
On November 17, FDA issued a Draft Guidance on Electromagnetic Compatibility (EMC) of Medical...
Conducting Field Reliability Tests for Medical Device Quality Management Is an Important Element in...
Follow these important reliability testing steps to assure success! How do you know whether a...
