Three Essentials for a Good Clinical Study Report
Learn the key elements of a compelling CSR for medical device success with NAMSA’s expert guidance.
Month: February 2024
ASCA Accreditation: FDA Annual Report and NAMSA Customer Experience
When it comes to medical device development, regulatory compliance is essential. In the United States, the Food and Drug Administration (FDA) is responsible for regulating medical devices and, specifically, their Accreditation Scheme for Conformity Assessment (ASCA Program) provides accreditation to laboratories that assess medical devices for compliance with regulatory requirements.
MDR Vigilance: New MDCG Guidance Published
This blog covers the EU Commission’s newly published MDCG Guidance documents relating to medical device and in vitro diagnostic medical device vigilance.
Embracing Digital Health Technologies: FDA’s New Guidance for Clinical Trials
This blog covers the FDA issued guidance on using digital health technologies for remote data acquisition in clinical investigations, allowing for remote data collection from trial participants.
European Commission Updates Chemical Classification and Labeling
This blog covers the latest updates to the European Commission’s harmonized classification and labeling of chemicals, including significant changes to the CLP Regulation that could impact medical devices.