ISO 13485:2016 Medical Devices Quality Management Certification

What is ISO 13485?

ISO 13485 is the internationally recognized standard for quality management in the medical device industry. It demonstrates the ability to consistently provide medical devices that meet regulatory requirements and customer expectations.

Who Needs ISO 13485 Certification?

Medical device manufacturers, component suppliers, contract manufacturers and distributors worldwide.

Key Benefits

✓Mandatory for medical device export globally

✓Required for CE marking in Europe

✓Access to US FDA and Health Canada markets

✓Demonstrates regulatory compliance

✓Essential for hospital and clinical supply contracts

✓Foundation for global market access

Documents Required

▸Quality Manual for medical devices

▸Design and development records

▸Risk management files (ISO 14971)

▸Device History Records (DHR)

▸Complaint handling procedures

▸Post-market surveillance records

▸Sterilization validation records

▸Regulatory submissions documentation

Certification Process

Free Consultation — We assess your needs and confirm the right standard

Gap Analysis and Documentation — We prepare all required documents

Training and Implementation — We train your team and guide implementation

Internal Audit — We conduct a thorough pre-certification audit

Certification Audit — IAF-accredited CB conducts the official audit

Certificate Issued — Verifiable on IAF CertSearch globally!

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Get ISO 13485 Certified

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TIMELINE

10-16 weeks

Other ISO Standards

ISO 9001 — Quality Management System ISO 14001 — Environmental Management System ISO 45001 — Occupational Health & Safety ISO 27001 — Information Security Management ISO 22000 — Food Safety Management System ISO 50001 — Energy Management System View All Standards →

Medical Devices Quality Management