ISO 13485 Medical Devices Quality Management System

The world's most recognised medical device standard helps organisations of all sizes.

Gain the market confidence you need to reach your goals.

We employs over 150 medical device experts with experience in all aspects of the product life cycle including research and development, manufacturing, and quality assurance.

Mitigate future risk and manage compliance – especially as your position in the global market shifts. BSI has multilateral agreements with many countries so that our test reports for a wide range of products can be accepted.

What are the benefits of ISO 13485 Medical Devices?

  • Increase access to more markets worldwide with ISO 13485 certification

  • Outline how to review and improve processes across your organisation

  • Increase efficiency, reduce costs and monitor supply chain performance

  • Demonstrate that you produce safer and more effective medical devices

  • Meet regulatory requirements and customer expectations

Access to Global Markets

By working with Us, medical device manufacturers are choosing to seamlessly access global in-house experts with regulatory experience in a wide-range of products and technical areas. Our experts have extensive hands-on experience in all aspects of the product life cycle including R&D, manufacturing and quality.

We are an approved “full scope” Notified Body recognized by the European Commission for 17 Directives and also hold recognition by FDA (US), CMDCAS (Canada), JPAL (Japan), ZLG/ZLS (Germany), and (Australia under MRA),Taiwan FDA (under TCP program), and HongKong MDCO (under HKCAB). We offer a results-focused portfolio of products and services for each stage of your certification journey, and we are committed to establishing long-term, proactive relationships with our customers.

ISO 13485 Training courses

PECB Certified ISO 13485

Foundation

PECB Certified ISO 13485

Lead Auditor

PECB Certified ISO 13485

Lead Implementer

Next steps

Whether you're starting the certification process, looking to transfer or just need to discuss options for your business, contact our expert team who will guide you through the process.