MDSAP Remote and Hybrid Pilot Program: Key Insights
MDSAP remote and hybrid pilot program was launched to modernize medical device audits by introducing digital flexibility while preserving regulatory rigor. It emerged as a response to global challenges while ensuring manufacturers remain compliant across multiple...
Benefit-Risk Analysis for 510 (k) Clearance: 4 Key Elements
US FDA 510(k) clearance is a premarket notification pathway for medical devices intended for U.S. market entry. This pathway is essential for devices that are not exempt from FDA 510(K) and is not already legally marketed. Additionally, it is required for devices that...
CE Marking for Class I, II, and III Medical Devices: A Guide
CE marking is a mandatory requirement for medical devices sold in the EU/EEA. It demonstrates compliance with EU MDR safety, performance, and quality requirements. The process involves classification, conformity assessment, technical documentation, and post-market...
10 Key EU MDR Cybersecurity Requirements for Medical Devices
In the modern healthcare system, every connected device can be a potential entry point for hackers. Protecting these systems ensures that innovative digital medical devices remain safe, reliable, and trusted. Hence, cybersecurity is vital in the medical device...