Module 12 Presentations

29/01/2024

Technical File

Risk Management

Clinical Evaluation

Pre-clinical Study

Label and IFU

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Technical Documentation

Data extracted from:

1. Device description and specification

• Device description and specification • Information about previous device generation or similar device on the market

IFU, brochures, design, competition

2. Information supplied by the manufacturer 3. Design and manufacturing information

• Labels • Instruction for use

Labels (software), IFU

• Steps for device development • Information and full specification • Disclosure of all sites (Design, manufacturing, critical suppliers, EM)

Design SOP, validation, inspection, purchasing

4. GSPR

Annex I, test reports, standards, common specification…

• Annex I – Compliance demonstration

5. Benefit-riskanalysisand risk management 6. Product verificationand validation

• Benefit risk analysis (section 1 & 8 – annexI) • Solution and result of the risk analysis (section 3 – annexe I)

Risk management file, usability, clinical evaluation Protocols, test results, biocompatibility, PMS plan & PSUR, PMCF

• Pre-clinical & clinical data • Specific cases

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©Copyright Easy Medical Device GmbH

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