Top 5 QMS Gaps in Combination Product Development

Top 5 QMS Gaps in Combination Product Development

Combination Product Industry News & Guidance Sharing device-related information and wisdom that will help you succeed Last week the alert came on in my SUV that in 500 miles I needed an oil change. I thought to myself “I am a smart and handy woman who could probably...
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...