How Medical Device Cybersecurity Evolved From Idea To Industry Imperative
With recent requirements, the FDA is taking a hard stance: cybersecurity is a core consideration with compliance being ...
Mid Day8d
Strategies for Medical Device Manufacturers to Overcome MDR 2017/745 Compliance Challenges and Secure CE Certification
Europe, comprising 27 EU member states, is one of the world’s largest and most advanced markets, serving over 500 million ...
Forbes26d
From Pills To Devices: How Pharma Is Expanding Into The Medical Device Market
Expanded Quality Management: Medical devices require rigorous quality management ... In a recent collaboration, an IoT-driven drug-delivery system significantly improved patient outcomes by ...
JD Supra3d
FDA Finalizes Guidance on Predetermined Change Control Plans for AI-Enabled Medical Device Software
On December 4, 2024, the U.S. Food and Drug Administration (“FDA”) released its final guidance for industry on predetermined change control ...
Med Device Online9d
How Does FDA Harmonization With ISO 13485 Impact U.S.-Focused Companies?
FDA’s harmonization of the Quality System Regulation with ISO 13485 was long expected. Aligning 21 CFR 820 with ISO 13485 ...
medtechdive12d
The power of composability: Overcoming field service management challenges in MedTech
Composable software seamlessly integrates with core systems, facilitating communication and real-time data sharing between ...
JD Supra10d
Three Questions with Sedgwick’s Jeremy Schutz
In this edition of Three Questions, health care & life sciences partner Nate Brown spoke with Jeremy Schutz, director of business development, ...