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Understanding medical device regulation: An introduction for innovators image

Innovative medical devices and diagnostics play a key role in delivering new products that benefit the NHS, the economy and above all, patients. To keep up with advances in science and technology, the regulatory landscape is changing.

The new regulations have an impact on everyone involved with medical devices, from their manufacture to their use. The changes are significant and it is important that innovators have a strong understanding of the processes involved when developing compliant devices for healthcare settings.

Scottish Health Innovations Ltd (SHIL) have teamed up with NHS Greater Glasgow and Clyde’s Medical Devices Unit (MDU) to host an informative webinar on Thursday 25 November.

Led by SHIL’s Head of Regulatory Affairs, Elaine Gemmell, and MDU’s Technical Operations Manager, Robin Sayer; it is aimed at Scottish-based SMEs, researchers and NHS employees involved in healthcare device innovation, the session will include:

  • How to prepare to meet existing and future regulations
  • If the UK and EU medical device regulations apply to your device
  • An introduction to quality systems and technical files
  • Regulations and governance for use in the NHS
  • How the NHS and SHIL can support your device development and regulatory compliance


Register now

Stay up to date with latest news via @ScotHealthInno

Regulatory information is available to view on www.shil.co.uk/regulatory/. This includes an overview of the key changes, implications and support available to ensure compliance with the new regulations.

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