by Lori Skope | Mar 5, 2024 | Blog
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...
by Jeff Kim | Jul 25, 2023 | Blog
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...
by Steve Badelt | Jun 30, 2023 | Blog
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...
by Jonathan Amaya-Hodges | Jun 14, 2023 | Blog
Combination Product Industry News & Guidance Sharing device-related information and wisdom that will help you succeed Are You Managing Your Combination Product Supplier Relationships Well Enough? Unless you are a company that “does it all” (and at the time of...
by Carolyn Dorgan | May 30, 2023 | Blog
Combination Product Industry News & Guidance Sharing device-related information and wisdom that will help you succeed Nine Ways To Make Sure You Are Selecting The Right Device Constituent Supplier Congratulations! You have found a device that fits requirements for...
