Module 14: Design Development and Certification of Medical Devices

17/11/2023

Factors affecting the success of sterilisation..(1)

• STATUS OF INCOMING RAW MATERIALS

• CLEANING AND DISINFECTION PROCEDURES • USED ON THE DEVICE • CONTROL OF THE MANUFACTURING ENVIRONMENT • CONTROL OF EQUIPMENT AND PROCESSES

Masterclass: Lecture 11

The Organisation for Professionals in Regulatory Affairs

9

Factors affecting the success of sterilisation..(2)

• CONTROL OF PERSONNEL AND THEIR HYGIENE • TYPE OF MEDICAL DEVICE PACKAGING • STORAGE CONDITIONS FOR THE DEVICE.

Masterclass: Lecture 11

The Organisation for Professionals in Regulatory Affairs

10

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