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.

We work with both – startups and big healthcare projects aimed at designing software solutions to reduce human data entry errors and duplicative processes.

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.

What is Software as a Medical Device (SaMD)?

Software intended for medical purposes — diagnosis, prevention, monitoring or treatment — that works on its own, without being part of a hardware medical device.

What regulations apply to medical device software in the EU?

The EU Medical Device Regulation (MDR 2017/745), together with standards such as IEC 62304 for the software lifecycle and ISO 14971 for risk management.

What documentation is required for certification?

A full technical file: software requirements and architecture, risk analysis, verification and validation records, usability documentation and post-market surveillance procedures. We prepare it as part of the development lifecycle.

Can you join an existing medical device project?

Yes. We can join at any stage — from planning a new device to preparing documentation and closing gaps in an existing project ahead of certification.