Benefit from our many years of experience in the field of medical device testing

What is the goal of testing in the field of medical devices?

The primary goals of medical device testing are patient safety, quality assurance, product guarantee, and compliance with international regulations, such as the MDR (Medical Device Regulation-EU), thus ensuring its marketability. According to international regulations, the packaging of your sterile and non-sterile medical device should protect your product from damage, contamination, and, if applicable, loss of sterility.

By selecting appropriate standards for packaging tests and medical device testing, you can identify potential weaknesses preventatively or analyze them retrospectively. Medical device testing is important to ensure that products are reliable and safe for patients and users, and that there are no risks. The tests support the design and development of medical devices and their packaging. The tests are indispensable for approval, such as CE marking.

How is the most fitting test method selected?

The appropriate testing procedure is always tailored to our customers' needs: you provide us with the standardized testing procedure and the standards according to which we will 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 testing laboratory of ISTA (International Safe Transit Association), we are also happy to support you with our expertise for this purpose. Naturally, we also carry out a variety of physical-mechanical tests on the medical device itself.