Documentation / Testing
What use is the best development of a medical device if it cannot be approved afterwards?
To prevent this, our competent experts ensure that the necessary documentation is generated right from the start. This includes not only the creation of meaningful requirements specifications and detailed concept documents, but also the documentation that accompanies the development process. This now accounts for an ever-increasing proportion of the development effort.
With our product documentation, you can go to any approval authority with confidence.
For us as a service provider, the quality level of our development results is our top priority. This is the only way we can guarantee our customers that we have developed what they want – and that the resulting product is also approvable.
The area of product testing therefore includes verification of regulatory requirements in addition to verification of our customer’s product-specific requirements. On the one hand, we realize this through tests in our laboratories; on the other hand, we organize and accompany the testing in accredited test laboratories. Thanks to our very good network, we often achieve shorter turnaround times here than has become customary in the meantime. We are also happy to support our customers in validation, be it in usability validation, customer acceptance tests or clinical studies.