Verification and Validation
The verification and validation processes are a means for testing and confirming the product features, whether these are done as part of the feasibility tests or under the standardization and regulatory requirements. We perform this process in cooperation with the customer, dividing these duties in a manner suitable to the company goals and its budgetary requirements.
As an ISO:13485 certified company, Integer is committed to implementing verification and validation processes, which for the most part include the following tests:
- Functional tests
- Electronic and electricity safety ISO:60601
- Software validation
- Packaging tests
- Sterilization tests
- Biocompatibility tests ISO:993
Integer supports the product and the customer from the test specification stage through their execution, the results analysis, the delivery of professional interpretation and their presentation to the relevant authorized entities. The company carries out the verification and validation process in accordance with the customer’s requirements, both at the company’s laboratories as well as at specialized laboratories. The equipment is calibrated and maintained in accordance with the manufacturer instructions and regulatory standards.