Product documentation/product testing
What good is the best development of a medical device if it cannot be approved in the end?
In order to avoid this situation, our competent experts ensure that the required documentation is produced from the outset. In addition to preparing informative requirement specifications and detailed concept documents, this also includes documentation in the course of development. This accounts for an ever-growing proportion of development effort today.
You can take our product documentation to any approval authority with confidence.
For us as a service provider, the quality of our development results comes first. As a result, we can guarantee to our customers that we have developed what they wanted – and that the resulting product is eligible for approval.
In addition to verifying the product-specific customer requirements, product testing therefore encompasses reviewing the regulatory requirements as well. We realise this on the one hand through tests in our laboratory and, on the other hand, we organise and administer testing in accredited test laboratories. Thanks to our excellent network, we often realise shorter throughput times than commonly accepted today. We are also happy to assist our customers with validation, including usability validation, customer acceptance tests and clinical studies.