Medical device software development

We understand well the sensitive nature of patient data, and that’s why we implement security into every layer of the software. Our team introduces end-to-end encryption, multi-factor authentication, access controls, and real-time threat detection into healthcare software. Every step of the way, we stay aligned with FDA, MDR, EMA, HIPAA, and GDPR requirements to ensure data stays protected.

There’s no definitive answer to this question, as timelines can vary depending on complexity. Typically, it takes around 6–12 months from the project's inception to the submission-ready MVP, but if you need a more accurate timeline estimate for your software, just escríbenos.

Absolutely. Innowise designs medical device software with interoperability in mind, supporting HL7, FHIR, and DICOM healthcare standards. Whether you need to connect SaMD with an EHR system or a wearable device, we ensure seamless data exchange and smooth app operation.

Yes, scalability is built in from day one. We use modular, cloud-ready architectures that can grow along with your needs. If, later on, you decide to add new features or will experience an influx of new users, you won’t need to rework your app from scratch, thanks to a thoughtful approach to medical device software architecture.

SaMD and SiMD costs entirely depend on the complexity of the features, required integrations with other IT systems, wearables, medical devices, relevant compliance requirements, and many other factors. If you need an estimate of your project costs, just Contacto, and we will provide you with a calculation based on your project requirements.

With over 18 years of industry experience, Innowise is a medical device software development company that has successfully delivered dozens of projects. We hold an ISO 13485 certification, proving we are well-equipped to develop medical device software and SaMD of any complexity. This certification is essential for FDA and MDR clearance of the software.