UK & EU Medical Device Classification
Automates regulatory classification assessments for Software-as-a-Medical-Device (SaMD) under UK MDR and EU MDR frameworks.
This skill acts as a regulatory architect for software teams building health-tech products, streamlining the complex process of identifying regulatory obligations. It evaluates intended use statements against UK MDR 2002 and EU MDR 2017/745 (Rule 11) to determine medical device classification, marking pathways (UKCA/CE), and conformity assessment routes. By mapping project data to international standards like ISO 14971 and IEC 62304, it helps developers and regulatory specialists generate standardized assessments for SaMD and AI-driven medical tools.
주요 기능
01Marking pathway analysis for UKCA, UKNI, and CE marking
021,999 GitHub stars
03Generation of post-market surveillance and vigilance obligation checklists
04Scope determination using MHRA Stand-Alone Software decision trees
05Automated classification under UK MDR 2002 and EU MDR 2017/745 Rule 11
06Mapping to safety standards including ISO 14971 and IEC 62304
사용 사례
01Assessing the regulatory impact of AI features in medical software (AIaMD)
02Determining if a health-tech application requires UKCA or CE marking
03Generating preliminary technical documentation for regulatory submissions