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The full SaMD lifecycle: analysis, software validation, development, QA, deployment and process documentation, in line with the Medical Device Regulation, FDA requirements and international standards. For startups and large healthcare projects alike.
We design software that reduces human data-entry errors and duplicated processes, and we prepare the certification evidence as part of the development lifecycle, not after it.
Our team’s experience developing software as a medical device is backed by knowledge of the EU Medical Device Regulation, healthcare regulatory requirements and safety risk management.
Case study: how to develop and certify a medical device.
“Hitech was most impressive with how quickly [they] understood our unique medical application needs and [their] ability to leverage their medical experience to get up to speed in a very short period of time.”
Software intended for medical purposes — diagnosis, prevention, monitoring or treatment — that works on its own, without being part of a hardware medical device.
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.
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.
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.
We’ll reply within one business day with next steps.
