Combination Product Industry News & Guidance Sharing device-related information and wisdom that will help you succeed Medical device and combination product developers looking to integrate or connect software have three new FDA standards to add to their regulatory...
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Product Industry News & Guidance Sharing device-related information and wisdom that will help you succeed Newest FDA Draft Guidance on Prescription Drug-Use-Related Software Will Be a Tool on Your Journey to Filing Success The FDA has shared a new draft...
