Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

Where to begin..

• What does quality mean to you (Quality Policy)? • What do your customers or regulations need from you? • Defining quality objectives relevant to company vision • Describe how quality processes are run and interact with each other (Quality Manual, procedures) • Who is responsible for quality processes? • How are you recording your actions?

The Organisation for Professionals in Regulatory Affairs

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The pushback…

Insight

 “ Why are we adding additional complexity?”  “We can’t afford to do this!”  “This is delaying getting products on market!”  “We only have 3 people in the company!”

“Effective implementation of a QMS will add value to any organisation.

Much of what is described in the

standard is already performed as part of natural company growth.”

 Here is why…

The Organisation for Professionals in Regulatory Affairs

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