Learn about the MDR, IVDR, ISO 13485:2016 and MDSAP on our dedicated revisions pages.
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:
Find out more about all of our services.