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Medical Device Vigilance Agreement Template

This 12-part contract with an appendix contains necessary agreements and controls to avoid any misunderstanding that may lead to a test result or work of unsatisfactory quality. If you wish to outsource your medical device testing activities, you must ensure that the data and reports received are correct and that the legal requirements for medical devices for testing in 17025 and Good Laboratory Practice (BPL) and ISO 13485 are met. A test agreement is an important step to meet regulatory requirements and, secondly, to protect the interests of your business. The test laboratory has an integrated quality management system that meets international standards for quality management and quality systems for medical devices, including international vigilance and traceability requirements (EN ISO 13485 or equivalent). In this context, preference is given to the use of accredited testing methods or trials, which are set by law. The review is conducted on the basis and implementation of U.S. EU guidelines and guidelines, EN, ISO and CIS standards, legislation, national technical standards, safety techniques, health and environmental protection regulations, and/or internal testing programs and methods. Where there are legal requirements, they are mandatory. 1. Preface 2. The subject of Agreement 2.1.

Definitions 2.2. Application field 2.3. Administrative information and responsibilities 3. General prescriptions 4. Test 4.1. Test bases 4.2. Test location 4.3. Samples and samples 4.4. Responsibility for the drug during trials 4.5. Tests 4.6.

Test results 4.7. Test report 4.8. Selected samples 4.9. Validation of internal method 4.10. Control devices 5. Personal Qualification, Health and Safety 5.1. Staff Qualification 5.2. Health, safety and environment 6.

Publications and confidentiality 7. Subcontractors 8. Disclosure requirement 9. Right to exam 10. Stop exam 11. Cancellation of a test 12. Responsibility 13. Payment commitments 14. Fixing mark 15.

Appendix 1 – Responsible personnel.