Module 14 2022

22/03/2022

Declaration of Conformity

Document that is signed to confirm that based on the information presented in the STED, the Device:

• Complies with the GSPR

Device is therefore fit for purpose

Masterclass Lecture 8

The Organisation for Professionals in Regulatory Affairs

31

STED Life Cycle Maintenance

REMEMBER: The STED is a LIVING document

It needs to be MAINTAINED and kept up to date as more information is gathered on the device during use, and if any updates/changes are made Do the changes affect the: • Risk Assessment? • Essential Principles?

Masterclass Lecture 8

The Organisation for Professionals in Regulatory Affairs

32

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