Latest Medical Device Industry News & Trends

SOCIAL MEDIA COPY FOR CROSS PROMOTIONAL PARTNERS

August 10, 2022

EUDAMED is planned to become mandatory by Q4 2024!

July 18, 2022

Providing food & essentials directly to those in need in Nova Kahovka, Ukraine Now!

May 12, 2022

Help our friends!

Overview of Premarket Notification 510(k) - Frequently Asked Q&A

March 18, 2022

What is a 510k? Who needs to submit a 510k? When is a 510K required? and more questions are going to be addressed in this document!

Comparison of current final software guidance vs new draft guidance

March 18, 2022

FDA has released a draft guidance document for industry to guide sponsors on evaluation of device software’s safety and effectiveness. “The recommendations in the new draft guidance document pertain to device software functions, including software in a medical device (SiMD) and software as a medical device (SaMD)”. The new draft guidance has in depth recommendations for every Software documentation element needed to be included in any premarket submission.