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Regulatory Services

Global market access for medical device manufacturers

With a global network of over 5,000 colleagues supported by 12,000 industry experts in more than 193 countries across a range of industries

We work with international regulators to support medical device manufacturers globally in bringing compliant products to market efficiently through the assessment of their medical devices and QMS.

Why choose BSI to access global markets

As a medical device manufacturer, by choosing to work with BSI, you will benefit from our team of experienced, professional, and well-qualified in-house experts with a wide range of regulatory and technical expertise.

We have extensive hands-on experience in all aspects of the device life cycle, from research and development to manufacturing and quality assurance.

What is BSI's role in global market access?

As a leading full-scope Notified Body, UK Approved Body and recognized MDSAP Auditing Organization, we hold several other statuses across the globe:

  • Registered Certification Body in Japan assessing against PMD Act and Ministerial Ordinance MO 169.

  • MDA Registered CAB in Malaysia conducting GDP & Product Verification under the MMD Regulation 2012.

  • SAC accredited Certification Body in Singapore conducting GDP for Med Dev against SS620 standard.

  • Recognised CAB in Egypt by the Egyptian Organisation for Standards for UKAS ISO 13485 accreditation.

  • Recognised CAB in South Africa, by SAHPRA, for RvA and UKAS ISO 13485 accredited certificates.

  • Recognised TFDA and AAO Partner with respect the Taiwan Technical Co-Operation programme.

How BSI can support your global market access

The benefits of having experienced, professional and well qualified experts cannot be overstated in the complex and ever-changing medical device industry.

BSI Medical Devices has a team of over 1000 colleagues; within that team are our technical experts with experience encompassing the full range of medical devices and management system standards.

Clients choose us because we understand the challenges medical device manufacturers face in bringing compliant devices to market efficiently and safely. We offer a range of flexible standard and dedicated review services providing you with efficient pathways to bring your device to market.

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Our global expertise for your medical device

Our core competencies and unique skills are calibrated to handle our customer's extensive portfolio of medical technologies.

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Reach out and see how we can help guide you on your path to sustainable operational success.

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