Smarter, connected devices are transforming healthcare. Your software must be secure, reliable, and built for performance. Our expertise in medical device software development ensures that your product:
Enhances patient outcomes with real-time insights
Improves operational efficiency and automation
Meets stringent regulatory and cybersecurity requirements
Integrates with EHR/EMR, cloud, & IoT ecosystems
16+ Years in MedTech & Healthcare Software.
FDA, HIPAA, MDR, IEC 62304, ISO 13485 Compliance.
Expertise in AI, IoMT, Cloud, and Embedded Systems.
End-to-End Development, from Concept to FDA Approval.
Build secure and compliant software across connected devices using our end-to-end medical device software solutions.
See how our healthcare software expertise helps businesses develop secure, connected, and innovative medical solutions.
We collaborate with MedTech leaders, healthcare organizations, and startups to develop next-gen medical device software solutions.
Developing software for FDA-approved devices
AI-driven analytics & data-driven medical insights
Custom medical software for clinical efficiency
Smart software for health tracking & remote monitoring
MVP development & regulatory compliance support
Our medical device software development process covers everything from discovery to post-launch support.
Understanding device specifications & clinical use cases
Compliance assessment & regulatory planning
Human-centered HMI interface design approach
Interactive wireframes & software mockups
Embedded, cloud, and AI-driven software solutions
Seamless integration with EHR, cloud, and IoMT ecosystems
Software verification, validation & usability testing
Regulatory documentation for FDA/MDR submissions
FDA/MDR regulatory approval assistance
Ongoing software maintenance, monitoring & security updates
Our custom medical device software development follows stringent regulatory requirements to ensure security, reliability, and compliance:
Medical Device Quality Management System
Software Lifecycle Processes for Medical Devices
Patient data privacy & security compliance
Software validation & electronic records compliance
Regulatory standards for European markets
Build secure, compliant medical device software development solutions that support patient safety, AI, and IoMT innovation.
Schedule a Discovery CallTimelines depend on device classification. But most Class II software projects reach submission readiness within four to six months of design freeze. Our medical device software development process builds FDA documentation into every sprint instead of leaving it for the end.
You retain full ownership of the source code, documentation, and any patents that result from the engagement. We work under a standard IP assignment agreement signed before development begins. Nothing we build for you gets reused for another client.
Check for direct experience with your device class and the standards that apply to it, such as IEC 62304 or ISO 13485. A capable medical device software development company should be able to show prior FDA submissions or MDR technical files on request. Ask specifically about their post-market support model, since many vendors stop at launch.
Yes, our medical device software engineering services include scheduled vulnerability scanning and patch deployment after your device ships. We track CVE disclosures relevant to your software stack and issue fixes under documented change control. This keeps you aligned with FDA's post-market cybersecurity expectations.
Yes, we structure the software architecture once and map it against both FDA and MDR requirements in parallel. This avoids building two separate codebases for different markets. Most clients clear both regions within the same release cycle.
Yes, Mobisoft Infotech's custom medical device software development covers modernizing firmware and legacy codebases that no longer meet current security or interoperability standards. We assess what can be upgraded versus what needs a full rebuild before quoting any work. This protects your existing hardware investment where possible.
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