Medical Devices

We ensure patient safety while supporting timely market access for our clients' Medical Device products globally.

We provide our customers with thorough, responsive, robust conformity assessments, evaluations and certifications that are recognized and accepted worldwide.

Maintaining quality; delivering excellence

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

• A designated European Notified 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

Find out more about all of our services.

Supporting you throughout the product lifecycle

Regardless of which stage you are at, BSI can work with you to minimize your corporate risk and ensure you remain compliant.

Talk to us early to take advantage of our full range of services.

You can check company, site and product certificates to validate the credentials or resources of a supplier or understand your competitor landscape. BSI’s directories will provide an extensive list of all current BSI certificates.