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 wisdomthat will help you succeed Don’t Delay – the EU’s Medical Device Regulation Takes Effect Soon UPDATED 8/3/2020 Developing medical device delivery systems...
Combination Product Industry News & Guidance Sharing device-related information and wisdomthat will help you succeed Brexit Implications & Guidance: Notified Bodies & the MDR If wrapping your brain around the new EU Medical Devices Regulation (MDR)...