1. Introduction: What is SaMD? Definition of SaMD Software as a Medical Device (SaMD) refers to software that is intended to perform medical functions without being part of a hardware medical device...
Background: Why PMS & PMCF are Game-Changers under EU MDR Regulatory Evolution: From MDD to MDR Under the previous Medical Device Directive (MDD 93/42/EEC), Post-Market Surveillance (PMS) and...
How The EU Medical Device Regulation (MDR 2017/745) came: Innovations, Challenges, and Opportunities
Background Context The EU Medical Device Regulation (MDR 2017/745) came into force in May 2021 (with transition timelines extended to 2028/2029 in some cases via Regulation (EU) 2023/607). It...