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). 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. 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. Cornell`s Routine Product Testing Agreement (RPTA) is a mechanism by which an examiner can enter into a contract with a customer to test a product or adequacy device as part of a test protocol developed by the customer.
The Routine Testing Agreement (RPTA or PTA) aims to facilitate routine testing agreements by providing a pre-approved set of testing conditions. CONSIDERING, PixelPlus is a semiconductor construction company that deals with business design, marketing/sales of CMOS IMAGE SENSOR products, and Lana is a testing service for semiconductors; and one. Preface 2. The subject of Agreement 2.1. Definitions 2.2. Application field 2.3. Administrative information and responsibilities 3. General requirements 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. Test 4.6. Test results 4.7. Test report 4.8. Selected samples 4.9. Validation of internal method 4.10. Control instruments 5.
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 obligations 14.
Commitment mark 15. Appendix 1 – Responsible personnel Most laboratory studies include the type of basic research that makes it difficult to predict whether an invention may result from the study, so we protect ourselves by including a contractual clause that allows the university to possess such inventions. But there is a class of laboratory studies that we will call test agreements, for which we can predict with certainty that there will be no academic inventions. This is very similar to the conclusion we draw for clinical trials; but, it does not apply to all, or even to most laboratory studies. The trick is to classify a laboratory study accurately, so that we only need the intellectual property of the university if it is useful to us and not if it does not more than hinder the negotiation of study conditions. The purpose of this checklist is to help you classify laboratory studies based on who wrote the protocol, how detailed it is, and whether it requires a simple review or more detailed analysis of the data. Please use the checklist for sponsored research agreements to verify all laboratory studies on standard problems presented by sponsored research agreements.