How the clinical evaluation is presented and referenced in the medical device technical file under UK MDR 2002 — the Clinical Evaluation Report, its relationship to other technical file elements, and post-market update requirements.
The design and manufacturing information required in a medical device technical file under the UK MDR 2002 — design inputs and outputs, verification and validation, manufacturing process documentation, and quality system records.
What the device description and specification section of the technical file must contain under the UK MDR 2002 — product identification, intended purpose, design specifications, variants, and accessories.
What the technical file must contain under UK MDR 2002, how it is structured, the difference between a technical file and a design dossier, UKAB access requirements, and how the technical file must evolve throughout the device lifecycle.