Global market access

Global market access

We offer a wide range of proven regulatory and quality management programs that work together for full international compliance

We offer a wide range of proven regulatory and quality management programs that work together for full international compliance
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Medical device market access
Medical device market access
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Global market access for medical device manufacturers

With a global network of over 4,600 colleagues and over 84,000 clients operating in 195 countries across a range of industries, we work with international regulators to support medical device manufacturers all over the world in bringing their products to market efficiently while complying with the latest regulatory requirements.

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 product and technical expertise.

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

What is BSI's role in global market access?

We are a global organization, trusted and recognized around the world with 84 offices in 31 countries. BSI The Netherlands (2797) is a leading Notified Body; we review medical devices to ensure that they conform to the requirements of the European Directives and Regulations. BSI UK (0086) is a UK Approved Body able to provide conformity assessments under the new UKCA scheme.

We hold recognition by SCC (CMDCAS, Canada), MHLW (PMD Act, Japan), Taiwan FDA (TCP program), Malaysian MoH (as a Malaysian CAB), and ANVISA (INMETRO, Brazil). We are also recognized as an MDSAP Auditing Organization.

We offer a 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.

Learn how BSI can support your access to these markets

How can BSI support your global market access?

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

BSI Medical Devices has a team of over 750 colleagues; within that team are our technical experts with experience encompassing the full range of medical devices and management system standards.

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

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

Find out more about the notified body >