Module 14 2022

General Safety & Performance Reqs.

Have applicable and non-applicable requirements been clearly noted with appropriate and relevant rationales ?

Has the “ precise identity of the controlled documents offering evidence of conformity ” (Annex II, Section 4.d) been identified for each including document location?

Possible Questions

Have all other applicable Directives & Regulations (Animal Tissue, Machinery, PPE, eIFU, etc.) been identified?

Have applied standards, common specifications, and guidance's been identified, along with extent of compliance and version / year claimed?

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