ISO 13485: Medical Devices.
ISO 13485 is the quality management system standard for medical device manufacturers, ensuring products meet regulatory requirements and are safe for patients.
Medical Device
Quality Assurance.
ISO 13485 is designed for organisations involved in the design, development, production, installation, and servicing of medical devices. It is the primary quality management standard for the medical device industry.
The standard helps organisations manage risk, increase product traceability, and comply with regulatory requirements. ISO 13485 certification is often a prerequisite for market access in many countries.
ICB UK provides ISO 13485 certification for medical device manufacturers, helping ensure your quality management system meets the stringent requirements of the healthcare sector.
Get CertifiedKey Benefits of ISO 13485
How to Get Certified.
Application
Submit your application and scope of certification.
Audit
Our auditors conduct a comprehensive assessment of your systems.
Certification
Upon successful audit, you receive your certification.
Surveillance
Regular surveillance audits ensure ongoing compliance.