Regulation and quality for healthcare technology - EPSRC

Contents

Quality management

There is usually no requirement to introduce or adhere to formal quality management systems in an academic research environment.

Implementing a quality system in a research lab may help accelerate the translation of technologies, but comes with a significant burden in time, resources and flexibility. As such, this is only likely to be appropriate in research centres with a significant translational focus.

However, familiarising yourself with parts of these quality systems will allow you to consider implementing elements within your normal research workflow. This makes it significantly easier to transition the technology’s development to a quality managed environment in the future.

For example, by understanding the standards relating to the sterilisation of medical devices, you can consider using materials and constructive methods compatible with cheaper and easier methods of sterilisation, resulting in overall reduced production costs.

What to consider around quality management

You should consider:

  • if you have an understanding of the testing and manufacturing requirements of your technology
  • if you intend to produce medical technologies ready for clinical evaluation within your research centre.

Resources to request

As part of your proposal you should consider requesting resources to:

  • undertake relevant training in quality management systems, international standard – ISO 13485, good laboratory practice, good clinical practice and good manufacturing process
  • employ people with relevant expertise on the project
  • engage with professional technology consultants
  • engage with NHS medical physics and qualified persons.

For large investments only, resources may be requested for the design and implementation of a formal quality management system.

Further information

Medicines and Healthcare products Regulatory Agency Good Practice, Inspections and Enforcement – guidance on topics including good laboratory practice, good manufacturing practice and others from the UK regulator.

Food and Drug Administration (FDA) Quality System Regulations – an introduction to US quality system regulations.

ISO 13485 medical devices – the international standard (ISO) for medical devices.

Last updated: 17 August 2021

NOTE Council web content is being transitioned to this website – let us know if you have feedback or would like to help us test new developments.