DiA42 - Gesellschaft für digitale Medizinprodukte mbH

We at DiA42 stand for design, development, data services, market access and support for digital medical devices (SaMD). We work in line with the following standards: ISO 13485 (Quality Management System), ISO 14971 (Risk Management), ISO 27001 (Information Security), IEC 62366 (Usability Engineering), IEC 62304 (Software Lifecycle), IEC 81001-5-1 (Cyber-Security), GDPR/ DSGVO (Data Protection), MDR (Medical Devices Regulation). Our customers are manufacturers of pharmaceuticals and medical devices, medical service providers, specialists and clinics. You already have contents or a concept for a digital therapeutic or preventive medical product, but you don’t want to spend your energy and resources primarily on fulfilling regulatory requirements? You want to test an existing prototype in a clinical trial? The focus on your core competencies and a quick market access is more important to you than doing everything yourself? Then we are your partner for development, market access, maintenance and support, turning your therapeutic concept into a digital medical product and bringing it successfully on the market. This could be as a digital medical device, DiGA, long-term care application (DiPA) or as a registered preventive product. We also participate in and support research projects in digital medical care. Your aim is to bring an innovative therapeutic approach on the market, but your research consortium needs strong project coordination, an active partner, or a member on an advisory board? We can fulfill these responsibilities and bring the necessary expertise in market access and regulatory affairs to make your project successful. Call us at +49 351 89697410 and let us discuss how we can make your digital therapeutics a success for you and for the patients! PS: We also talk HL7v2 and FHIR. ** Imprint & data privacy: https://www.dia42.de (clickable link under "website") **