Medical Devices
Medical Devices
Supporting your medical device business to ensure patient safety
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:
- A designated European Notified Body
- A UK Approved Body
- An accredited ISO 13485 Certification Body
- A recognized Auditing Organization under the Medical Device Single Audit Program (MDSAP)
- A recognized Certification Body in many global markets
Support throughout the product lifecycle
