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.
Build Regulatory-Grade MedTech Software
IEC 62304-compliant medical device software from $2,500/month. Start in 48 hours.
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