Passionate about patient safety

Our mission is to ensure patient safety whilst supporting timely market access to global medical device technology. We strive to set the global  standard in thorough, responsive, robust conformity assessments, evaluations and certifications that are recognized and trusted worldwide.

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.

Maintaining quality, delivering excellence

BSI Medical Devices offers certification services to support your global market access goals. We are: