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We can offer a seamless service with comprehensive support and the absolute minimum level of disruption.
We understand that having confidence in your Notified Body and Approved Body to deliver an efficient and robust CE marking and UKCA marking, and a thorough Quality Management System assessment process is important. Our approach focuses on open communication from the very beginning, and your application will be supported by a dedicated team of medical device experts. We can offer a seamless service with comprehensive support and the absolute minimum level of disruption.
Experience and product expertise
Global market access
Committed to patient safety
Trusted and robust reviews
Thorough and responsive services
The European Medical Device Regulation (MDR) replaced the MDD and the AIMDD. Entered into force on 25 May 2017 with 26 May 2021 date of application.
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The In Vitro Diagnostic Regulation (IVDR) replaced the IVDD and entered into force on 26 May 2017 with 26 May 2022 as date of application.
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ISO 13485 is a harmonized and internationally recognized standard for quality management systems (QMS) in the medical device industry.
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Whether you're starting the certification process, looking to transfer or need to discuss your options, we can guide you through the process.
