Combination Product Industry News & Guidance Sharing device-related information and wisdom that will help you succeed Cybersecurity: Consider the Network, Not Just the Device We wanted to share this Seattle Times article, “Why health care has become a top target for...
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 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Product Industry News & Guidance Sharing device-related information and wisdom that will help you succeed Newest FDA Draft Guidance on Prescription Drug-Use-Related Software Will Be a Tool on Your Journey to Filing Success The FDA has shared a new draft...