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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
Frame 1000005946

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.

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Client quote

Although we were confident in our set of documentation, we were pretty much agnostic regarding the UK regulation and expectation. Apotech made our life easy and ensured a very seamless process to approve our device on the UK market. Thank you!

Key numbers

Management

Team

1 QARA Consultant

Charity

Location

UK

Combo Chart

Length

3 year

WeChat

Type

UKRP Service

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Are you searching for bespoke, flexible outsourced services for your Biotech or MedTech projects? Apotech offer a comprehensive range of consulting services for biologics, medical devices and other pharmaceutical products. Our extensive team of Regulatory, Quality and Engineering Consultants provide a world-class service to clients, large and small.