Module 5 Presentations

16/07/2024

Premarket and Postmarket device studies

Technical / Analytical Validation

Clinical Development/ Validation

Registration and Approval

Postmarket Requirements

Quality System/ Development

Intended Use

Classification

Robustness Biocompatibility Sterility Human factors

Some combination devices can use Drug Quality System

MDR brings increased clinical evidence requirements

Implantables are high risk

Physical

Modular software architecture Agile development; many rapid iterations

Human factors Endpoint qualification Evolving trial requirements

Software validation Algorithm training/

Qualification as medical device IMDRF principles for classification

Registration regulations evolving Pre-cert pathway

Cybersecruity monitoring

testing AI/ ML

Digital Health

Reproducibility Limit of Detection Accuracy NGS requires special framework

Joint EMA review for CDx, NGS- service, software, or system

Trials with Companion Diagnostics

Quality metrics for NGS workflow

Advanced Diagnostics

M-GB-00018492 Date of preparation: July 2024

13

Performance study and Clinical investigations : Roche submission experience

M-GB-00018492 Date of preparation: July 2024

14