NEXTEC medical GmbH
We help with all regulatory and clinical CE topics for medical devices, especially software, DiGA and DiPA. On request, we also place your products on the market and act as manufacturer, so you can focus entirely on marketing!
Our passion is medical device regulation, especially in the emerging field of digital health and AI. We actively support CE, DiGA, DiPA and DTx projects. In the past, our clients increasingly asked whether we could also act as the legally responsible party for their products, for example for DiGA. We now fulfil this request as the core of our service. With ISO 13485 and 27001 certifications, we are ideally positioned to take on this role.
- Qualification and classification of medical devices - Clinical strategy: do I need a study for my CE marking? - Study designs - Regulatory roadmaps - Implementation of technical documentation - Implementation of a QM system according to ISO 13485 and/or ISO 27001
- Assessing DiGA/DiPA eligibility - Support with the clinical strategy - Support with the requirements of DiGA Annex I and Annex II
- Acting as legal manufacturer (e.g. for medical apps, DiGA, DiPA and other medical devices) - Acting as EC REP or UK REP
