Medical Device Software
Development Services

Cost is mostly shaped by safety class and validation effort, not by how fast code gets written.

• Basic medical device software or low-risk systems usually land between $60,000 and $120,000
• SaMD products and mid-level platforms often fall in the $120,000 to $300,000 range once verification and documentation are included
• Safety-critical or multi-device systems can cross $300,000 and go beyond $600,000 when audits, integrations, and controls expand
• The biggest cost factors are IEC 62304 safety classification, FDA or MDR scope, and medical device integration and interoperability needs
• Ongoing costs don't disappear after launch. Post-market updates and controlled changes are part of custom medical device software solutions development.

Our experts can offer you exact cost estimates based on your custom business requirements. Get in touch with our team now!

No physical device is required for SaMD, but the software still has to be treated like a regulated product from day one.

• Intended medical use has to be clear early because it sets the regulatory path
• Input data can come from simulations, historical datasets, or controlled clinical data at the start
• Verification work can begin before deployment, especially for logic and data handling

From a regulatory view, SaMD follows the same discipline as other medical device software and life cycle planning still applies. As a medical device app development services provider, we help teams define intended use, validation scope, and regulatory-ready workflows even before hardware or live deployments exist.

There’s no single timeline, but most medical device software programs fall into a familiar range when things are scoped properly.

• Early discovery and architecture usually take about 4 to 8 weeks
• Development and verification often run 3 to 6 months, depending on complexity
• Validation and integration can add another 2 to 4 months, especially if hardware is involved

In practice, full software development for medical devices typically spans 6 to 12 months, including SaMD programs. Timelines stretch when requirements keep changing or regulatory prep starts late.

Medical device software shows up in more places than people expect once you look beyond firmware.

• Embedded control software that runs directly on the device hardware
• Companion applications that sit on phones or desktops and talk to the device
• Clinical dashboards used by healthcare teams to review readings and trends
• SaMD platforms that work independently for diagnosis or monitoring
• Integration layers built for medical device interoperability with hospital systems

Being a renowned medical device app development company, we work across all these layers, helping teams design, build, and maintain regulated software that stays reliable from device operation through clinical use and long-term lifecycle updates.

FDA expectations are handled as part of everyday engineering work, not as paperwork added at the end.

• Design controls are followed during development, not retrofitted later
• Engineering outputs feed directly into DHF, risk files, and verification records
• Traceability is maintained between requirements, code changes, and tests
• Experience across all FDA device classes (Class I- low risk, Class II- moderate risk, Class III- high risk), applying the appropriate level of oversight and controls for each.
• Teams usually work alongside in-house regulatory and quality groups

This applies across all custom medical device software and SaMD programs.

FDA validation is about keeping behavior bounded and understandable, not about chasing perfect accuracy scores.

• Intended use is defined tightly, so the AI component has clear limits
• Training, testing, and validation datasets are controlled and versioned
• Performance boundaries and failure behavior are documented early
• Any model update goes through a change impact review before release