by Jonathan Amaya-Hodges | Feb 27, 2024 | Blog
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...
by Jonathan Amaya-Hodges | Feb 14, 2024 | Blog
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)...
by Jonathan Amaya-Hodges | Nov 16, 2023 | Blog
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...
by Jonathan Amaya-Hodges | Oct 3, 2023 | Blog
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...
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...
