IL Training - Design Control Basics

Which is/are not a valid Design Phase?

Phase 0: Scoping Phase

Phase 3: Design Transfer Phase

Phase 6: CAPA Phase

Phase 1: Design Input Phase

Phase 2: Random Prototyping Phase

Phase 4: Design V&V Phase

What does DDP stand for?

Design Development Plan

Design Development Process

Design Draft Procedure

Development Design Project

Which function leads the Architecture Description Team?

Systems Engineering

Marketing

R&D Director

Project Manager

What is an Essential Output?

A design output that is essential to the proper functioning, safety and intended use(s) of the device.

A design input requirement that is essential to the proper functioning, safety and intended use(s) of the device.

Which element/s below are generally considered significant design changes and thereby call for the use of a Scaled DDP?

New addition(s) or change(s) to design inputs

Execution of new or existing V&V protocol(s)

Regulatory submission for design or major labelling changes

Design Change Project > 10M USD

Design Change Project Team > 25 FTEs

Design Changes that can be justified in an engineering report

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