BSI Group

For more than 125 years, BSI has been making a profound and unique contribution to the well-being of the world. Our independence, global reach, and access to leading experts set us apart. Thanks to our unique corporate structure, we reinvest our profits to foster progress and partnerships, thereby strengthening trust among consumers, governments, and organizations. 

Ultimately, we help businesses and society thrive together, thereby accelerating progress toward a just society and a sustainable world.

In the area of Regulatory Services, we guide you on your journey toward meeting global standards, promoting safety, and strengthening your customers’ trust. As the world’s first national standards organization, we set the bar for regulatory excellence with our unmatched global expertise and our longstanding commitment to the public good and innovation.

As your independent, market-leading experts in patient safety, we facilitate effective market access for medical devices. Our services include:

• CE Certification
• UKCA certification
• ISO 13485 certification
• MDSAP certification – Medical Device Single Audit Program

In the medical device sector, cross-team collaboration has led to improved support for those of you dealing with regulations for medical devices (MD) and in vitro diagnostic medical devices (IVD), resulting in the issuance of well over 2,500 certificates to date.

As a result, we are expanding our global presence and solidifying our position as one of the world’s most trusted Notified Bodies in this field.

Across the entire medical device sector, we support:

• 24 of the 25 leading manufacturers worldwide
• 83% of small manufacturers
• From startups to global market leaders