ISO 13485 Medical Devices

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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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 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 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.

Introduction & Implementing ISO 13485 Medical Devices training course >

  • ISO 13485 shapes quality management systems for medical device manufacturers the world ever
  • We will explain how ISO 13485 is implemented and draw links with other quality standards
  • BSI's Implementing ISO 13485 course has been designed to provide you with the knowledge and process steps to enable them to effectively implement a Quality Management System in line with the requirements for ISO 13485 certification. The course introduces the concepts needed to understand, develop, and implement a quality management system
Rp3750000

3 days classroom based training course

Internal Auditor for ISO 13485 >

  • BSI's Internal Auditor ISO 13485 course is intended for medical device quality professionals aiming to build on thier current knowledge of ISO 13485 and evaluate the effectiveness of the quality management system in thier organization. This intensive course teaches the principles and practices of effective quality management systems process audits in accordance with the ISO 13485 and ISO 19011. An experienced instructor guides students through the internal audit process, from planning an audit to reporting on audit result and following up on corrective actions.
  • Participants will gain necessary auditing skills through a balance of formal classroom tutorials, practical role-playing, and group workshops.
Rp3750000

3 days classroom based training course