Software as a medical device (SaMD)
Introduction
Our client designs and sells a CE marked Class IIa software, used in cardiology as a digital twin.
Types
- Regulatory affairs
- Responsible person
- FSP
Scope of work
Our client recently partnered with groups of clinics in the United Kingdom and therefore asked us to act as their UK Responsible Person. In less than 5 days, our consultant reviewed all documentation, uploaded the requested information on the MHRA portal, and received approval from MHRA. Apotech also delivered training on how to register with the MORE portal.
Key numbers
Team
1 QARA Consultant
Location
UK
Length
3 year
Type
UKRP Service
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