Combination Product Industry News & Guidance Sharing device-related information and wisdom that will help you succeed The Impact of the QMSR Final Rule on Combination Product Developers and Manufacturers On February 2, 2024, the Food and Drug Administration (FDA)...
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...
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 Industry News & Guidance Sharing device-related information and wisdom that will help you succeed We are excited to announce that Kelly Wedig is Suttons Creek’s newest Senior Consultant, reporting to Director of Technical Services, Jonathan...
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...
