Combination Product Industry News & Guidance Sharing device-related information and wisdom that will help you succeed Have you reviewed the FDA’s final guidance on human factors for combination products? Our team of CP experts have made a cheat sheet of key points...
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 Are You Managing Your Combination Product Supplier Relationships Well Enough? Unless you are a company that “does it all” (and at the time of...
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...
