ISO 13485 Medical Device Certification and Regulatory Compliance Audit

This opportunity involves engaging a UK Approved Body (such as BSI) to conduct two-stage external audits (Stage 1 and Stage 2) for medical devices to achieve ISO 13485 Quality Management System certification. The engagement is urgent and timeline-driven, with deliverables ensuring that medical devices meet internationally recognized standards for safety, effectiveness, and reliability. Due to upcoming UK medical device regulation changes in Spring 2026, many currently self-certified, low-risk Software as Medical Devices (SaMDs) will be reclassified as higher-risk and will require mandatory external certification. Without this certification, organizations face an innovation freeze preventing the launch of new or updated SaMDs and AI-assisted Medical Devices (AIaMDs), along with significant legal, reputational, and operational risks to NHS England. This is a statutory obligation rather than a discretionary activity. Suppliers should be prepared to deliver comprehensive regulatory compliance services within agreed timelines to meet this critical deadline.