EU MDR General Safety and Performance Requirements (GSPR) have recently been updated. The latest changes in EU MDR GSPR have introduced stricter expectations around cybersecurity, clinical evidence, environmental impact, and AI/ML devices. While core compliance areas,...
The Medical Device Single Audit Program (MDSAP) is a global framework that satisfies the regulatory requirements of multiple countries. MDSAP reduces duplication and ensures consistent quality product oversight. It is now recognized by several major regulators...
Medical device single audit program (MDSAP) is a comprehensive audit framework designed to meet regulatory requirements of multiple participating countries. MDSAP post‑market surveillance requires manufacturers to maintain a harmonized, risk‑based system for...
Navigating Canada’s medical device approval pathway can feel overwhelming. The process of obtaining medical device approval in Canada is complex and requires strict adherence to Health Canada’s regulatory framework. For organizations seeking market entry,...
Legacy devices are products that were legally certified under older directives (MDD) but are allowed to remain in EU market. The EU MDR has released new guidelines for legacy devices. Legacy devices will have to mandatorily comply with these guidelines to...