
Developing a Technical File for Medical Devices: A complete guide
The Medical Device Manufacturing Centre (MDMC) is pleased to announce the delivery of a new free workshop on The Complete Development of a Medical Device Technical File, using a birthing mirror as a practical case study
This free workshop will be delivered by Elaine Gemmell, Head of Regulatory Affairs at InnoScot Health, and run in a hybrid form: online will be through Teams, while in-person will run at Heriot-Watt University, Edinburgh EH14 4AS (room: EMG.61).
Understanding the structure, content, and purpose of a medical device technical file is essential for anyone involved in the design, manufacture, or regulation of medical devices. A well-prepared technical file not only demonstrates compliance with regulatory requirements but also ensures that design, safety, and performance are fully traceable and justified.

Register to attend
The aim of this workshop is to provide a comprehensive overview of the complete development of a medical device technical file, from concept to compliance.
Through interactive sessions and case-based discussions, participants will learn how to compile, structure, and manage the documentation needed to support conformity assessment under the UKCA and EU MDR frameworks.
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