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On November 17, FDA issued a Draft Guidance on Electromagnetic Compatibility (EMC) of Medical...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...

While the pharmaceutical industry works toward recovery from the effects of the COVID-19 pandemic,...

Okay, your goal is clear. You have eight months to absorb 4,000 labels into your system. The...

You’re called into a multi-departmental meeting. You’ve heard rumors that your company has...