Medical Device Software (SaMD)
We develop Software as a Medical Device (SaMD) following IEC 62304, FDA 21 CFR Part 11, and EU MDR requirements. From AI-powered diagnostic algorithms and clinical decision support systems to patient monitoring software and companion apps for medical devices, we handle the full lifecycle including design controls, risk management, and regulatory submission documentation.
Why This Matters
SaMD is the fastest-growing segment in medical devices. But one regulatory misstep can delay your launch by 12-18 months. Engineering with compliance from day one is non-negotiable.
What You Get
Every capability included in this service
Clinical Algorithms
Develop and validate AI/ML-based diagnostic algorithms with clinical study design, performance characterization, and bias analysis for regulatory submission.
Design Controls
Full traceability from user needs → design inputs → design outputs → verification/validation with automated DHF generation.
Continuous Compliance
Post-market surveillance, CAPA management, and complaint handling workflows integrated into your CI/CD pipeline for ongoing regulatory compliance.
Real-World Applications
How companies use medical device software (samd) to drive results
Technology Stack
Technologies we use for medical device software (samd)
Industries We Serve
This service is tailored for these industries
Ready to Build Something Extraordinary?
Let's discuss how we can transform your ideas into powerful digital solutions. Free consultation, no commitment.