ISO 13485 Medical Devices

The world's most recognised medical device standard helps organisations of all sizes. The world's most recognised medical device standard helps organisations of all sizes.
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ISO 13485 Medical Devices
ISO 13485 Medical Devices
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Gain the market confidence you need to reach your goals.

BSI 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 certification
  • Outline how to review and improve processes across your organization
  • Increase efficiency, cut 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 BSI, 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.

Popular Medical Devices training courses

Design and develop medical devices to international quality standards, ensure smooth submission, meet ISO 13485 standards, satisfy customers and keep ahead of all regulatory developments with our medical devices training courses.

ISO 13485:2016 Medical Devices Quality Management Systems (IRCA Certified) Auditor/ Lead Auditor Course >

This course teaches the principles and practices of effective quality management systems and process audits in accordance with ISO 13485 and ISO 19011, “Guidelines for Quality and/or Environmental Management Systems Auditing.” Experienced instructors guide students through the entire audit process, from managing an audit programme to reporting on audit results.


5 days classroom based training course

Why choose BSI?

We pioneered standards more than 100 years ago and today we’re the market leader. We help over 80,000 organizations ranging from top global brands to small ambitious businesses in 172 countries worldwide to gain an edge over their competition. As one of the few organizations that understands standards from start to end, we don’t only assess how well you’re meeting them, we create new standards from scratch and train teams globally to use them and perform better. Our knowledge can transform your organization.