ISO 22442-2-2020 Medical devices utilizing animal tissues and their derivatives – Controls on sourcing, collection and handling. Requirements, application, and auditing. Requirements, application, and auditing.

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You will learn the requirements of ISO 22442-2:2020 for controlling the sourcing, collection, and handling of animal tissues and their derivatives used in medical devices.
The course covers key MDSAP concepts, regulatory requirements, audit processes, and the benefits of MDSAP participation for medical device manufacturers. You will also gain an understanding of how MDSAP audits support compliance across multiple international jurisdictions.

Course Content

Acknowledgements and Attestation

Submit Acknowledgements and Attestation

Introduction

1 Scope

2 Normative references

3 Terms and definitions

4 General requirements

5 Sourcing

6 Collection

7 Handling

8 Storage, transport and labelling

Annex A (normative) Additional requirements relating to the application of this document to bovine-sourced materials and other TSE relevant animal species

Annex A (normative) Additional requirements relating to the application of this document to bovine-sourced materials and other TSE relevant animal species
A.1 General
A.2 General aspects
A.3 The likelihood of infectivity in the source animals A.3.1 General
A.3.2 The BSE status of the countries or regions of origin A.3.2.1 General
A.3.2.2 Negligible BSE risk
A.3.2.3 Controlled BSE risk
A.3.2.4 Undetermined BSE risk
A.3.2.5 Particular circumstances
A.3.3 Sourcing from closed herds starting material
A.3.4 The age of the donor animals
A.3.5 The feeding history of the donor animals
A.4 The infectivity of the source tissue
A.5 Measures to prevent cross-contamination

Annex B provides an example of a certification as fit for human consumption and an example of a heath attestation.

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A course by

Mark Durivage

Consultant, Auditor, Educator & Author

What Will You Learn?

Course Content

Acknowledgements and Attestation

Submit Acknowledgements and Attestation

Introduction

Introduction

1 Scope

1 Scope

2 Normative references

2 Normative references

3 Terms and definitions

3 Terms and definitions

Terms Quiz

4 General requirements

4.1 General

4.2 Quality system elements

4.3 Procedures

4.4 Personnel

4.5 Current regulatory requirements and guidance

General Requirements Quiz

5 Sourcing

5.1 General

5.2 Species and strain

5.3 Geography

5.4 Inspection

5.5 Certification

5.6 Traceability

Sourcing Quiz

6 Collection

6 Collection (6.1)

6 Collection (6.2)

6 Collection (6.3)

Collection Quiz

7 Handling

7 Handling (7.1)

7 Handling (7.2)

7 Handling (7.3)

Handling Quiz

8 Storage, transport and labelling

8 Storage, transport and labelling (8.1)

8 Storage, transport and labelling (8.2)

8 Storage, transport and labelling (8.3)

8 Storage, transport and labelling (8.4)

Storage Quiz

Annex A (normative) Additional requirements relating to the application of this document to bovine-sourced materials and other TSE relevant animal species

Annex A (normative) Additional requirements relating to the application of this document to bovine-sourced materials and other TSE relevant animal species

A.1 General

A.2 General aspects

A.3 The likelihood of infectivity in the source animals A.3.1 General

A.3.2 The BSE status of the countries or regions of origin A.3.2.1 General

A.3.2.2 Negligible BSE risk

A.3.2.3 Controlled BSE risk

A.3.2.4 Undetermined BSE risk

A.3.2.5 Particular circumstances

A.3.3 Sourcing from closed herds starting material

A.3.4 The age of the donor animals

A.3.5 The feeding history of the donor animals

A.4 The infectivity of the source tissue

A.5 Measures to prevent cross-contamination

Annex B provides an example of a certification as fit for human consumption and an example of a heath attestation.

B.1 Example of a certificate to be issued

B.2 Example of a health attestation to be issued by a veterinarian

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