1. Introduction to EHR Interoperability Definition and Core ConceptElectronic Health Record (EHR) interoperability refers to the capability of different healthcare information systems, devices, and...
1. Introduction The Emergence of AI and ML in Healthcare Artificial Intelligence (AI) and Machine Learning (ML) have emerged as transformative forces in the healthcare industry. Their capacity to...
Understanding Clinical Evaluation Reports (CERs) in EU MDR Definition and Purpose of Clinical Evaluation Reports (CERs) A Clinical Evaluation Report (CER) is a critical technical document required...
1. Understanding the Term “Legacy Devices” Under EU MDR Definition of Legacy Devices under EU MDR Under the European Union Medical Device Regulation (EU MDR 2017/745), “legacy devices” refer to...
1. Definition & Regulatory Context Definition of Custom-Made Devices (CMDs) Under Article 2(3) of the EU MDR, a custom-made device is defined as any medical device specifically made in accordance...
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...
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...