Testing of component and device dimensions and functionality is an integral part of device development. Testing of a new device starts as soon as the first prototypes have been manufactured during the innovation phase. As the product is refined during the development program, testing becomes more stringent. Most important is the Design Verification at the end of a development or customisation project. The device must prove that it fulfils all device requirements that have been defined during the design input phase and that it conforms to all regulations, such as ISO11608.
Ypsomed performs all related mechanical, functional and dose accuracy measurements in-house in its Competence Center Laboratory (CC Lab). Like the Concept and Product Development department, the CC Lab is located at Ypsomed’s headquarters in Burgdorf, Switzerland. This allows our development engineers to directly be involved in the important testing process.
At Ypsomed, design verification is an integral part of each device project. All equipment required for device verification is available in-house, and the necessary lab resources are reserved during the project planning phase. With the lab located at our headquarters, primary containers containing drug or placebo can be shipped to Switzerland and conveniently stored within Ypsomed’s access controlled, walk-in cold storage room. Special testing methods that are used to test the final product, may be conveniently transferred from the CC Lab to the customer, e.g. for release testing of devices.