As a leading full-scope Notified Body and UK Approved Body, our comprehensive services encompass every aspect of regulatory compliance. We are:

  • A leading full scope Notified Body (2797)
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  • A leading full scope UK Approved Body (0086)
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  • An accredited ISO 13485 Certification Body
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  • A recognized Auditing Organization under the Medical Device Single Audit Program (MDSAP) Find out more

  • A testing laboratory for electrical medical devices, our worldwide market access solutions include IEC 60601 testing for ensuring the electrical safety and essential performance of your medical device, UKCA and CE marking services and IECEE CB Scheme certification – enabling access to over 50 global markets with a single test report. Find out more

  • Artificial intelligence (AI) in medical devices
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Meet us at booth F52 (Hall 10) to discover how our regulatory services, combined with our world-leading experience, provide efficient pathways to help you achieve your global market access objectives.

 

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