Module 14 2022

14/03/2022

Important Considerations

• Verification activities should always be on production-equivalent devices.

• If the final device does not include AM, it cannot be used for verification.

• But...AM can be used to support verification e.g. test fixtures.

Developers should be aware how AM is implemented within the design process .

The Organisation for Professionals in Regulatory Affairs

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Selecting a Process

Device Form Development

Cup Seal Development

Proof of Concept: Functional Level

Proof of Concept: High Level

The Organisation for Professionals in Regulatory Affairs

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