In general
The regulatory foundation for medical devices
ISO 13485 aligns your processes with international regulatory expectations and places rigorous risk management across the product life cycle — protecting patients and reducing the likelihood of costly recalls.
It is the QMS foundation for MDSAP, a core expectation under EU MDR, and since February 2026 the US FDA’s Quality Management System Regulation (QMSR, 21 CFR Part 820) incorporates ISO 13485 by reference.
Benefits
Benefits of ISO 13485 certification
- Faster access to global markets through regulatory alignment
- Efficient cycle times and reduced waste
- Greater trust from distributors, hospitals and end users
- Stronger supply-chain transparency and supplier control
- A culture of continual improvement that adapts to new technology and clinical demands
How it works
Your path to ISO 13485 certification
- 01Service agreementThe engagement begins with a signed agreement and a dedicated project team.
- 02Gap analysisWe assess your current practices against ISO 13485:2016 and prepare a detailed action plan.
- 03Documentation and implementationWe develop procedures and records, train your team and embed the system into daily operations.
- 04Internal auditA comprehensive internal audit confirms readiness and resolves any nonconformities.
- 05Certification auditAn accredited certification body audits and issues your verifiable certificate.
