HiTech Service provides full Software as a Medical Device Development Life Cycle for this device software including analysis, software validation, software development, QA, deployment, development of process documentation using latest technologies on the market and in compliance with Medical Device Regulation, European standards and best practices.
Software development and certification preparation process are done according to:
- US FDA Regulation requirements
- ISO 13485:2016 “Medical devices— Quality management systems — Requirements for regulatory purposes”
- EN/IEC 60601-1 “Medical Electrical Equipment and Systems”
- ISO 14971 “Medical devices — Application of risk management to medical devices”
- IEC 62304 “Medical device software — Software life cycle processes”
- IEC 62366 “Medical devices – Application of usability engineering to medical devices”
- Cybersecurity requirements
Our team has good experience in developing software as a medical device, backed up by knowledge in European Union Regulation of Medical Devices, Regulatory Requirements in Healthcare, Safety Risk Management.