ISO 22442-1-2020 Medical devices utilizing animal tissues and their derivatives – Application of risk management. Requirements, application, and auditing.

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What Will You Learn?

  • This course provides a practical understanding of ISO 22442‑1:2020, focusing on risk management requirements for medical devices that utilize animal tissues and their derivatives.

Course Content

Acknowledgements and Attestation

  • Submit Acknowledgements and Attestation

Introduction

1 Scope

2 Normative references

3 Terms and definitions

4 Risk management process

Annex A (informative) Guidance on the application of this document

Annex B (informative) Graphical representation of part of the risk management process for medical devices utilizing animal material

Annex C (normative) Special requirements for some animal materials considering the risk management for TSE agents

Annex D (informative) Information relevant to the management of TSE risk

Final Exam
This final exam is administered to demonstrate the participant’s understanding and comprehension of the course materials. A score of 80% or greater is required to receive a Certificate of Completion.

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