by Jonathan Amaya-Hodges | Jul 31, 2026 | Blog
Combination Product Industry News & Guidance Sharing device-related information and wisdom that will help you succeed The greatest challenge in combination product development isn’t technical – it’s organizational. Why organizational integration, not...
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 | Jan 23, 2023 | Blog
Combination Product Industry News & Guidance Sharing device-related information and wisdom that will help you succeed INDUSTRY NEWS BRIEF: When patient access to important therapy is delayed… If you’ve got a new combination product drug/device that will likely...
by Steve Badelt | Jul 7, 2022 | Blog
Combination Product Industry News & Guidance Sharing device-related information and wisdom that will help you succeed What happens when you need to switch your drug delivery device mid-development? Luckily, it does not happen often. But it does happen. Your drug...
