Scarlet is a mission-driven organisation.
Our daily decisions are guided by our long‑term vision of transforming global healthcare.
Our impact
We're proud that our customers are working on health conditions that impact hundreds of millions of people.
We enable them to certify their medical devices without unnecessary delays, and with the frequent iteration needed for the best software and AI.
Designations
We are accredited and regulated by:
- Scarlet is designated as an EU Notified Body under regulation EU 2017/745 EU MDR.
- Scarlet is designated as a UK Approved Body under UK Medical Devices Regulations 2002 (SI 2002/618 as amended).
- Scarlet is also accredited to issue ISO 13485 certificates.
- Scarlet is authorised and regulated to certify software and AI medical devices by the largest government agencies, including:
- ISO 17021-1:2015 certification by national accreditation agencies including UKAS and RVA
- Ministries of Health, such as the Dutch Ministry of Health, Welfare and Sport, and the UK Medicines and Healthcare products Regulatory Agency
- Pan-government entities, such as the Health Department (DG-Santé) of the European Commission
Advisors
We are supported by highly qualified advisors who bring significant experience from their illustrious careers.
John Wilkinson, OBE
Director of Medical Devices at MHRA 2012-2019
Chair of the Board of Trustees, GMDN (Global Medical Device Nomenclature)
Howard Kerr
CEO of BSI 2009–2021
Impartiality Panel
Scarlet has put in place an independent Impartiality Panel to ensure we adhere to the highest standards.
Dr Margarida Carlos
Former Head of Designation and Monitoring of Notified Bodies at MHRA
Pieter Erasmus
Experienced life sciences and healthcare regulatory lawyer
John Wilkinson, OBE
Director of Medical Devices at MHRA 2012-2019
Chair of the Board of Trustees, GMDN (Global Medical Device Nomenclature)
Our team
Scarlet is run by a world-class team of uniquely skilled experts.
We hire the best people, wherever they’re based. That’s why our team works remotely from across Europe and the US, as well as from our offices in London and Amsterdam.
Join us on our mission
Check out our careers page if you'd like to help us deliver the future of healthcare to the world.