Combination Product Industry News & Guidance Sharing device-related information and wisdom that will help you succeed Cybersecurity in Medical Devices: FDA Final Guidance Breakdown Last week, the FDA issued the final guidance “Cybersecurity in Medical Devices: Quality...
Combination Product Industry News & Guidance Sharing device-related information and wisdom that will help you succeed Helpful Links For Software-Connected Combination Product Development Are you developing software as a medical device (SaMD)? Below are links that can...
Combination Product Industry News & Guidance Sharing device-related information and wisdom that will help you succeed Newest FDA Draft Guidance on Prescription Drug-Use-Related Software Will Be a Tool on Your Journey to Filing Success The FDA has shared a new draft...
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 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...
