Medical device manufacturers use cytotoxicity testing to help prove that devices that come into contact with the human body are biocompatible. Testing results are critical for gaining market access, ...

Changing regulations are nothing new for regulatory professionals operating in the medical device sector, but 2022 cemented milestones no one in the profession can ignore. The fifth edition of ...

Chapter 21: Preparing a Medical Device Submission Chapter 22: US Marketing Pathways: 510(k), De Novo, PMA, HUD/HDE, Breakthrough Devices Chapter 23: European Marketing Authorization and CE Marking ...

Many Medtech startups view FDA and similar regulatory bodies as a roadblock. Something that is there to get in their way, slow them down, and cost them a fortune. Smart companies see regulations as an ...

In 2023, the Food and Drug Administration (FDA) took a more active approach to medical device cybersecurity. They issued new requirements for premarket submission and ongoing monitoring by medical ...

Medical innovation is exciting. It’s thrilling to think a new therapy, device or product can improve the quality of or save ...

In a constantly growing global medical device market, marked by increasingly strict regulation and rising demands in patient ...

As ‍ ‌‍ ‍‌ ‍ ‌‍ ‍‌ data-driven innovation profoundly changes every industry, the healthcare sector is also affected. Digital twins – virtual copies of physical devices – are essentially changing the ...

Key Takeaways Prototyping accelerates the medical device development journey, enabling rapid iterations based on user ...

Depending on the device category, transitional periods may extend for up to three years for general medical devices and up to five years for in vitro diagnostic devices, meaning that full ...

Artificial intelligence (AI) is no longer the future of healthcare—it’s already here. AI-driven medical devices are diagnosing diseases faster than doctors, guiding surgical procedures with precision ...