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Medical Device Regulations (MDR)

Published on 04 September 2020

The Clinical Informatics team make sure the Medical Device Regulations (MDRs) integrate with the delivery of solutions by National Services Scotland (NSS). MDRs are in place to ensure that all hardware and software used in a clinical environment or capacity, is suitable.

Clinical Informatics ensure the regulations are followed. This preparation offers a range of security monitoring and response capabilities for our national services and across all health boards in Scotland.

How Clinical Informatics can help

Medical Device Regulations response

We provide consultancy services and support throughout the product design lifecycle such as:

  • Early stage concept options
  • Clinical considerations in design
  • Remediation solutions and retrospective planning

Consultancy

Our team of clinical informaticians can guide you through every detail before you commit to a new design or solution.

Design solutions

We can ensure that your design solution considers all aspects needed to deliver a compliant solution.

Remediation

Clinical Informatics can help identify and mitigate risks in current solutions and at each stage of the delivery process. The earlier the intervention, the less impact there is likely to be.

Get in touch

To find out more about how clinical informatics can help you, send us an email (link invokes your email software).