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Revolutionizing Healthcare: The Rise of Medical Device Software and EU Regulatory Compliance

In the rapidly evolving field of healthcare technology, NAMSA provides expert guidance on navigating the complex regulatory landscape for Medical Device Software (MDSW) in Europe. The blog discusses the importance of clinical and performance evaluations according to EU regulations, highlighting the challenges manufacturers face in demonstrating safety and effectiveness. It emphasizes the need for thorough data analysis and risk assessment, particularly in areas like software safety, risk classification, and the lifespan of MDSW. NAMSA’s specialized medical writing teams offer their extensive expertise to assist MDSW manufacturers in achieving compliance and fostering innovation within the digital health space.

FDA Town Hall Series on Ethylene Oxide Sterilization and Alternative Sterilization Modalities

Explore FDA efforts to reduce EO use in medical device sterilization, the rise of VHP, and how NAMSA can assist with sterilization validation.

MDCG 2024-2: Procedures for the Updates of the European Medical Device Nomenclature

Learn about EMDN updates in the new MDCG 2024-2 guidance and its impact on medical device manufacturers.

Industry Update: Quality Management System Regulation (QMSR)

Explore FDA’s new QMSR aligning with ISO 13485, simplifying compliance for device makers. Get ready with NAMSA’s expert transition guidance.