UCL Therapeutic Innovation Networks


Laboratory/Pre-clinical Evaluation (Devices)

Highlighting requirements of the "Laboratory/Pre-clinical Evaluation" stage in order for successful medical devices translation.

Devices roadmap

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Target Product Profile (TPP) – captures the ‘benefit’ of the proposed medical device and key considerations in the strategic development of the product (incl. technical, scientific and medical information required to satisfy regulators and industry partners)

  • ISO 14971, Application of Risk Management to Medical Devices – An international standard for the requirements for risk management to determine the safety of a medical device by the manufacturer during the product life cycle.
  • ISO 62304, Medical Device Software - An international standard which specifies life cycle requirements for the development of medical software and software within medical devices.
  • ISO 60601, Safety Testing Electrical Devices - A series of technical standards for the safety and essential performance of medical electrical equipment.

UCL Support: 

The UCL Institute of Healthcare Engineering plays a large role in supporting the Devices TIN due to the institutes experience in transforming patient care with medical devices and digital technologies. 

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Does your research prototype match the Target Product Profile (TPP) and meet all the essential safety & performance requirements?

  • Prototype verification
  • ‘In-house’ versus contracted, external GLP-testing?
  • Scalable processes/considerations for ‘clinical’ manufacture?
  • ‘De-bugging’; iterative user & operator enhancements?

UCL Support: 

In most cases, the Joint Research Office (JRO) will support and oversee investigator-initiated, clinical evaluation of in-house medical device development programs at UCL. Early engagement with the JRO is essential to facilitate timely:

  • Foreword planning for evaluations to satisfy the regulatory authorities (e.g. MHRA, EMA, FDA)
  • Development of appropriate clinical manufacturing and research agreements, in partnership with UCL

Contact the JRO

For application to Clinical Engineering for permissions for device studies in UCL’s partner hospital, UCL support can be found through Research Services, UCLB and the TRO.