Clinical Investigations of Medical Devices

9:30-12:30 23rd January 2024 Virtual delivery (MS Teams)

Medical device research is an often misunderstood area, with many research staff unsure how to properly identify and categorise a device, and what the regulatory considerations for clinical investigations are. This 3-hour virtual workshop provides a detailed summary of the requirements for investigations of medical devices, focusing on the key topics, including:

• What is (and isn’t) a medical device? How are they categorised?

• The UK Medical Device Regulations (and a comparison with the EU Medical Device Regulations). Plus - What changes are on the horizon?

• ISO14155 overview

• CE and UKCA marking - what are the requirements?

• Software as a medical device

Fee: £140 per person (+ VAT) - to request a place on this workshop, please contact us via the link to the right.

AcoRD - Calculating & attributing the costs of research

9:30-12:30 6th February 2024 Virtual delivery (MS Teams)

This 3-hour virtual workshop provides an in-depth overview of AcoRD. Delegates will explore the attribution process for all costs associated with clinical research in the NHS, and the funding sources for each category of cost. We simply and clearly explain what is meant by a research cost part A, research cost part B, treatment cost, excess treatment cost, and service support cost. Additionally, we will have a detailed looked at the Schedule of Events Costing Attribution Template (SoECAT) and the excess treatment cost calculation/allocation process.

Fee: £140 per person (+ VAT) - to request a place on this workshop, please contact us via the link to the right.