Module 14: Design Development and Certification of Medical Devices

17/11/2023

GOOD DESIGN PRACTICE

DESIGN FEASIBILITY ● First step in the design process – BRAINSTORMING – LOOKING AT CONCEPTS

● OFTEN CALLED A PRODUCT INITIATION REQUEST – A PROCESS FOR FORMALLY DOCUMENTING AN IDEA

● Assessment by a MULTIDISCIPLINARY team

Masterclass: Lecture 1

The Organisation for Professionals in Regulatory Affairs

11

GOOD DESIGN PRACTICE - DESIGN PLANNING

● Time schedule ● Milestones

• Goals and objectives • Organisational responsibilities • Tasks • Resources

● COMMUNICATIONS! …when notifications should occur

Masterclass: Lecture 1

The Organisation for Professionals in Regulatory Affairs

12

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