Module 14: Design Development and Certification of Medical Devices

17/11/2023

DOCUMENTING THE DEVICE DEVELOPMENT

DEVICE DEVELOPMENT INFORMATION IS USED: ● TO CONSTRUCT THE DESIGN HISTORY FILE ● TO SUPPORT PATENT ACTIVITIES

IT IS REALLY IMPORTANT TO RECORD: ● DESIGN DECISIONS ● DESIGN CONTROLS

Masterclass: Lecture 1

The Organisation for Professionals in Regulatory Affairs

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THE IMPORTANCE OF DOCUMENTING THE DEVICE DEVELOPMENT

● DESIGN DECISIONS – INVESTIGATIONS THAT WORKED – AND THOSE THAT DID NOT

– LEARNINGS FROM THE DATA GENERATED – And how they influenced the next steps – RISKS MITIGATED / NEW RISKS IDENTIFIED – To understand the WHOLE picture – STUDIES TO CONFIRM COMPLIANCE WITH REGULATORY STANDARDS – Mandatory requirement! – INNOVATIVE APPROACHES – What clever solutions have you used?

Masterclass: Lecture 1

The Organisation for Professionals in Regulatory Affairs

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