Developing your medical device with start delays and capacity constraints because you have to familiarize yourself with the finesses of documentation first? You don't have to: Our experts in the fields of technical documentation, clinical evaluation, and regulatory affairs feel more than at home with these issues. And because they consider the regulatory requirements at every stage of the development process, they can provide really efficient support: from creating or updating the technical documentation during the development process in accordance with the Medical Device Directive, to providing support with registering (in accordance with MPKPV) and conducting clinical investigations, the wide spectrum of clinical evaluation to all questions related to the approval of medical devices (CE and international).
You have a specific question about your development? We are looking forward to getting to know you!