Module 14: Design Development and Certification of Medical Devices

17/11/2023

Biological Evaluation Report - 4

• Toxicological Assessment of Formulation/Device

• Toxicity statement on the whole product to include summaries of any additional studies conducted on device - Comment on appropriateness of label

- Conclusion - Signature

The Organisation for Professionals in Regulatory Affairs

23

Biological Evaluation Report - 4

• Toxicological Assessment of Formulation/Device - Appended to Technical File - Used in Risk Management Plan

The Organisation for Professionals in Regulatory Affairs

24

12