Supporting your medical device business

Our mission is to ensure patient safety while supporting timely access to global medical device technology. We strive to set the global standard in thorough, responsive, predictable conformity assessments, evaluations, and certifications – The BSI Medical Device Mission.

As a medical device manufacturer, there are a number of regulatory requirements you must meet before you can sell your devices on the international market. It is essential that your certification body has the capability and expertise to support you with robust product and system certification reviews, to ensure patient and user safety.

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