MedTech Software Development | Medical Device, FDA & Clinical Software
IEC 62304-compliant medical device software, FDA-regulated SaMD development, and clinical trial systems | built by engineers who understand regulatory requirements.
MedTech Development Services
Regulatory-grade software for medical device companies and digital health innovators
Medical Device Software (SaMD)
Software as a Medical Device development following IEC 62304 lifecycle | risk classification, design controls, verification & validation documentation, DHF preparation.
from $3,000/mo
FDA Submission Support
510(k) and De Novo documentation support, software description documents, cybersecurity documentation (SP 800-30), FDA pre-submission meeting preparation.
from $2,500/mo
Clinical Decision Support
CDSS algorithms, evidence-based scoring systems, drug interaction checkers, dosing calculators, diagnostic support tools integrated with EHR workflows.
from $2,500/mo
Clinical Trial Software
eCRF/EDC systems, randomization and trial supply management, pharmacovigilance data capture, 21 CFR Part 11 compliant audit trails.
from $3,000/mo
Medical Imaging & AI
DICOM viewer development, AI/ML diagnostic model integration, radiology workflow tools, PACS/RIS integrations, annotation platforms for training datasets.
from $3,500/mo
IoMT & Connected Devices
Firmware and cloud connectivity for connected medical devices | Bluetooth LE data capture, device management platforms, FDA cybersecurity post-market requirements.
from $3,000/mo
Why CodeMiners for MedTech?
IEC 62304 & FDA Experience
Engineers trained in medical device software lifecycle | software safety classification, design controls, risk management per ISO 14971, and validation documentation.
Documentation That Passes Review
We produce the SRS, SDS, V&V protocols, and traceability matrices regulators require. Not as an afterthought | as part of the development process.
Cybersecurity for Medical Devices
FDA cybersecurity guidance compliance | SBOM generation, vulnerability management, penetration testing, and post-market cybersecurity monitoring programs.
Who Needs Custom MedTech Software Development?
From regulated SaMD to clinical workflow tools, our medtech developers serve the full spectrum of medical technology companies.
Medical Device Manufacturers
IEC 62304-compliant SaMD, embedded firmware, FDA/CE submission documentation, Design History File (DHF), and cybersecurity post-market requirements.
Digital Health Startups
Patient-facing apps, wearable device integrations (BLE), remote patient monitoring platforms, and FDA breakthrough device program support.
Clinical Research Organizations (CROs)
Electronic Data Capture (EDC/eCRF) systems, 21 CFR Part 11-compliant audit trails, CTMS, randomization tools, and pharmacovigilance platforms.
Diagnostic & Imaging Companies
DICOM viewer development, AI-assisted diagnostic tools, PACS/RIS integrations, radiology workflow automation, and imaging AI annotation platforms.
Hospital & Health Systems
Clinical decision support (CDSS) systems, custom EHR integrations (Epic, Cerner HL7/FHIR), medication management tools, and care coordination platforms.
Pharmaceutical Companies
Patient adherence apps, eCOA/ePRO platforms, drug safety reporting tools, supply chain serialization, and clinical trial data management.
IoMT & Connected Device Makers
Bluetooth LE firmware, cloud IoMT connectivity platforms, FDA cybersecurity-compliant device management, and real-time patient telemetry systems.
AI/ML in Medical Imaging
Deep learning diagnostic models (radiology, pathology), FDA AI/ML-based SaMD frameworks, training data annotation platforms, and model validation pipelines.
MedTech Software Development Cost Comparison
Regulatory-grade medtech development at 65% below US agency rates — with full IEC 62304 documentation included.
| Project Type | CodeMiners | US Agency | US Contractor |
|---|---|---|---|
| Clinical Decision Support MVP | $15,000–$35,000 | $50,000–$120,000 | $25,000–$60,000 |
| SaMD (IEC 62304 compliant) | $30,000–$80,000 | $100,000–$250,000 | $60,000–$150,000 |
| eCRF / EDC Platform | $20,000–$50,000 | $70,000–$180,000 | $35,000–$80,000 |
| Medical Imaging Viewer | $25,000–$60,000 | $80,000–$200,000 | $40,000–$100,000 |
| Ongoing Dev Team (monthly) | From $2,500/mo | $18,000+/mo | $6,000–$15,000/mo |
| IoMT Device Platform | $20,000–$45,000 | $60,000–$150,000 | $30,000–$80,000 |
MedTech Software Development FAQ
Common questions about building regulated medical device software and digital health platforms.
What is medtech software development?
MedTech software development involves building custom software for medical devices, clinical systems, and digital health platforms — including Software as a Medical Device (SaMD), clinical decision support systems, medical imaging tools, clinical trial EDC platforms, and IoMT connected device software. CodeMiners develops IEC 62304-compliant medtech solutions from $2,500/month.
Do you have experience with IEC 62304?
Yes. IEC 62304 compliance is core to our medtech practice. We follow the full software development lifecycle including safety classification, design controls, hazard analysis, risk management per ISO 14971, V&V documentation, and Design History File (DHF) preparation — all required for FDA and CE mark submissions.
Can you support FDA 510(k) submissions?
Yes. We provide FDA submission support including software description documents, cybersecurity documentation per FDA guidance, software bill of materials (SBOM), pre-submission meeting preparation, and documentation for 510(k), De Novo, and PMA pathways.
What is SaMD and can you develop it?
Software as a Medical Device (SaMD) is software that diagnoses, treats, or monitors a medical condition without being embedded in a physical device — diagnostic algorithms, clinical decision support tools, and patient monitoring apps. We develop SaMD following IEC 62304 and FDA software guidance for non-hardware-embedded software.
How do you ensure HIPAA compliance?
We build HIPAA-compliant systems with AES-256 encryption at rest and in transit (TLS 1.3), role-based access controls, full audit logging, Business Associate Agreements (BAA) with cloud providers, automatic session timeouts, minimum necessary data access, and documented incident response procedures.
How much does medtech software development cost?
MedTech development at CodeMiners starts at $2,500/month for a dedicated team — 65% below US agency rates. A clinical decision support MVP typically costs $15,000–$35,000. A full FDA-regulated SaMD with IEC 62304 documentation typically ranges from $30,000–$80,000+. We provide fixed-price milestone quotes after a technical brief.
Build Regulatory-Grade MedTech Software
IEC 62304-compliant medical device software from $2,500/month. Dedicated medtech developers — start in 48 hours.
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