The U.S. Food & Drug Administration (FDA) has finalized its new Quality Management System Regulation (QMSR), which fully aligns with ISO 13485:2016.
Effective Date: February 2, 2026
Impact: Compliance with ISO 13485 will satisfy FDA’s QMSR requirements, with additional FDA-specific obligations still applying (e.g., MDR reporting, UDI, labeling, registration/listing).
What this means for you
- One Quality System: Manufacturers can now operate under a single ISO 13485-based QMS that satisfies both FDA and international expectations.
- Global Advantage: ISO 13485 certification is already required in Europe, Canada, Japan, and other markets — aligning early positions your company for smoother global market access.
- FDA Inspections: FDA investigators will begin using ISO 13485 as their inspection baseline, focusing on conformity plus FDA-specific requirements.
Why Act Now
Although 2026 may seem far away, most organizations need several months to complete certification activities, address any findings, and prepare teams for inspection. Beginning early reduces the risk of last-minute gaps.
Nemko’s Role
As a trusted certification body, Nemko supports U.S. medical device manufacturers in achieving and maintaining compliance:
- ISO 13485 Certification Audits aligned with FDA’s QMSR.
- Gap Assessments to benchmark readiness for QMSR enforcement.
- Supplier & Subcontractor Audits ensuring your supply chain is compliant.
- Integrated Certification Services (ISO 9001, ISO 27001, ESG, and more) for broader organizational needs.