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Description of the Quality Contracts - Testing Agreement for Medical devices
If you want to outsource your medical devices test activities you must make sure that the data and reports you receive are accurate and meet the Medical Devices regulatory requirements for testing EN 17025 and Good Laboratory Practice (GLP) as well as ISO 13485. A Testing Agreement is a key step to comply on the one hand the regulatory requirements and on the other hand protect your company’s interest. The Testing Laboratory shall maintain an integrated quality management system which satisfies the international standards for quality management and quality systems for medical devices, including the international requirements of vigilance and traceability (EN ISO 13485 or equivalent).
In this connection, preference shall be given to the application of accredited testing methods or tests laid down by statute. Test shall be based on and conducted following US guidelines and EC directives, EN, ISO and IEC standards, Statutory provisions, National technical standards, Safety engineering, health and environmental protection rules and/or In-house testing programs and methods. Where statutory requirements exist, they shall be binding.
This 12 pages contract template with one attachment specifies agreements and controls needed to avoid misunderstandings that could result in a test result or work of unsatisfactory quality.
Table of Content:
2. Subject of the Agreement
2.3. Administrative Information and Responsibilities
3. General Requirements
4.1. Test Bases
4.2. Testing Location
4.3. Samples and Test Specimens
4.4. Drug accountability during testing
4.5. Test Execution
4.6. Test Results
4.7. Test Report
4.8. Retained Samples
4.9. In-House-Method validation
4.10. Test equipment
5. Qualification of personnel, Health & Safety
5.1. Qualification of personnel
5.2. Health, Safety & Environment
6. Publications & Confidentiality
8. Duty to provide Information
9. Right to audit
10. Discontinuation of Testing
11. Cancellation of a Test
13. Payment Obligations
14. Binding Character
Appendix 1 – Responsible Personnel
Testing Agreement for Medical devices
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