Why choose BSI for your product compliance to the MDR?
Used for a wide range of treatments in various specialized fields, active medical devices represent a significant and profitable segment of the healthcare industry. As a manufacturer of active medical devices, one of your biggest challenges in breaking into – or continuing your success in – this market is navigating the regulatory process efficiently.
Our active medical device specialists are not just experienced in the regulations, they are product experts who understand the specifics of these devices.
BSI Medical Devices is justifiably proud of its status in the industry as a full scope Notified Body, which includes active medical devices. Nowhere is this more apparent than in our level of experience; our specialist Active Medical Devices team has 43 technical experts, 6 clinical specialists supported by a body of internal clinicians, and 10 dedicated support staff.