Module 5 Presentations

16/07/2024

Device development pathway: where pre-market and post-market clinical studies fit

M-GB-00018492 Date of preparation: July 2024

11

Drugs and Devices: Product Development Phases and Regulatory Backbone

Product Development Phases

Confirmatory Development/ Evidence Generation

Exploratory Development/ Feasibility / Prototyping

Commercial / Postmarket

Ideation/ Research

Medical Device Regulatory Backbone

Quality System/ Development

Technical / Analytical Validation

Clinical Development/ Validation

Registration and Approval

Postmarket Requirements

Intended Use

Classification

M-GB-00018492 Date of preparation: July 2024

12