Medical product testing

What is the goal of medical product testing?

The primary objectives of tests for the medical sector are patient safety, quality assurance, product safety and compliance with the requirements of the MDR (Medical Device Regulation - EU Medical Device Regulation) and thus its marketability. According to international regulations, the packaging of your sterile and non-sterile medical product should protect your product from damage, contamination and possible loss of sterility.

By selecting suitable standards for packaging tests and medical product tests, you can identify potential weaknesses preventively or analyze them afterwards. Medical product tests are important to ensure the reliability and safety of for patients and users and that there are no risks. The tests support the design and development of medical products and their packaging. The tests are essential for approval, such as CE marking.

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How is the most fitting test method selected?

The appropriate test method is always based on our customers' requirements: You specify the standardized test method and the standards according to which we test your product.

For the approval of your products, we offer accredited services in the field of packaging validation, including process, transport and shelf-life validation. As a certified test laboratory of the ISTA (International Safe Transit Association), we are happy to assist you with our expertise in this area. Of course, we also carry out various physical-mechanical tests on the medical product itself.