DiA42 - Gesellschaft für digitale Medizinprodukte mbH
Development, IT operations, quality management, information security, maintenance and support for digital medical devices: comprehensive services for your application.
DiA42 stands for the design, development, operation and support of digital medical devices (Software as a Medical Device/SaMD) in accordance with * ISO 13485 (QM system), * ISO 14971 (risk management), * ISO 27001 (information security), * IEC 62366 (usability), * IEC 62304 (software life cycle), * IEC 81001-5-1 (cybersecurity), * GDPR (data protection), * MDR (Medical Device Regulation). Together with clients from the therapy and prevention sectors, we develop digital medical devices and place them on the market. We also provide a modular service package to operate, further develop and maintain any digital products you may already have. We relieve your internal resources by taking over IT operations, support, information security and quality management. Where needed, we fill roles such as Quality Management Representative (QMR), Information Security Officer (ISO), Cybersecurity Officer and Person Responsible for Regulatory Compliance (PRRC). All at a predictable fixed price!
