Medical Devices

BSI offers medical devices 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

As we start the New Year, Dr Manuela Gazzard, Group Director of Regulatory Services at BSI, celebrates the achievements of the Medical Devices team in 2020, despite being a challenging year for us all. Manuela also provides an update on BSI’s leadership, the expansion of the Medical Devices team to support clients with IVDR, MDR and QMS applications, and the full-scope designation of BSI UK to the new UKCA scheme, as we remain committed to our mission of ensuring patient safety while supporting timely market access to medical device innovation.

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.

As the coronavirus COVID-19 outbreak evolves, the safety and wellbeing of our clients and colleagues is our highest priority, so please read our latest updates on how we are managing global audits and assessments.