Risk Management Assessment 101 for Combination Products

Risk Management Assessment 101 for Combination Products

Combination Product Industry News & Guidance Sharing device-related information and wisdom that will help you succeed Risk Management Assessment for Combination Products As a developer of combination products, it is your job – per ISO 14971:2019 and the EU MDR – to...
Creating A Design History File (DHF) That Gets Approval

Creating A Design History File (DHF) That Gets Approval

Combination Product Industry News & Guidance Sharing device-related information and wisdom that will help you succeed Creating A Design History File (DHF) That Gets Approval Combination products have unique design and regulatory requirements from those of drugs and...
Combination Product Social Quiz Answers

Combination Product Social Quiz Answers

Combination Product Industry News & Guidance Sharing device-related information and wisdom that will help you succeed Did you play the game on LinkedIn? Time to check your answers… August 3, 2023 LinkedIn Post The Question... What is the probability of a...