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
Capabilities
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
Use Cases
Technology Stack
Explore More
Related Services
HIPAA-Compliant Platform Development
Healthcare platforms built from the ground up with HIPAA, NABH, and DHA compliance baked in.
Learn MoreTelehealth & Telemedicine Platforms
Video consultation, remote monitoring, e-prescriptions, and virtual care platforms for providers.
Learn MoreEHR/EMR Integration Services
Seamless integration with Epic, Cerner, Allscripts, and custom EHR/EMR systems via HL7 FHIR.
Learn MoreCommon Questions
Frequently Asked Questions
How do you ensure HIPAA compliance in healthcare apps?
Masarrati implements end-to-end encryption, role-based access controls, audit logging, BAA agreements with cloud providers, secure data storage, and regular security assessments aligned with HIPAA technical safeguards.
Can you integrate with existing EHR/EMR systems?
Yes. Masarrati integrates with Epic, Cerner, Allscripts, and other EHR systems using HL7 FHIR, SMART on FHIR, and CDA standards. We build middleware that bridges legacy health systems with modern applications.
What telehealth features can you build?
Video consultations, appointment scheduling, prescription management, remote monitoring dashboards, secure messaging, e-prescribing, and integration with wearable devices — all HIPAA compliant.
How do you handle medical data security?
Through encryption at rest and in transit, PHI access controls, de-identification for analytics, secure cloud hosting (AWS GovCloud/Azure Healthcare), penetration testing, and SOC 2 compliance processes.
Can AI be used in healthcare applications?
Absolutely. Masarrati builds AI-powered diagnostic support, clinical decision systems, medical imaging analysis, predictive patient risk models, and NLP for clinical documentation — all with human-in-the-loop validation.
Real Results
Related Case Studies
MedInsight AI
An intelligent medical imaging analysis platform that assists radiologists with AI-driven anomaly detection, reducing diagnostic turnaround times by 65%.
HealthcareMedConnect Patient
A patient-facing healthcare app we engineered for our client — enabling appointment booking, teleconsultation, medical records, and prescription management in one seamless mobile experience.
HealthcareMedConnect Doctor
A comprehensive doctor portal we built for our client — managing appointments, teleconsultations, digital prescriptions, patient records, billing, and practice analytics from one dashboard.
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