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Developing a Technical File for Medical Devices A complete guide TEMPLATE

Developing a Technical File for Medical Devices: A complete guide

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Posted: 15-October-2025

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.

A woman taking part in a webinar on her laptop.

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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InnoScot Health works in partnership with NHS Scotland to identify, protect, develop and commercialise new innovations from healthcare professionals. Registered Number: SC 236303. Registered address: 272 Bath Street, Glasgow, G2 4JR
Office Address / Deliveries: Suite 203, The Pentagon Centre, 36 Washington Street, Glasgow, G3 8AZ

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