by Jonathan Amaya-Hodges | Sep 12, 2023 | Blog
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...
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 Lori Skope | Jul 11, 2023 | Blog
Combination Product Industry News & Guidance Sharing device-related information and wisdom that will help you succeed Suttons Creek is excited to announce its newest team member, Craig Voellmicke, who has taken on the position of Director of Sales. With more than...
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...
