Medical Device Software
IEC 62304-compliant engineering across the full software development lifecycle — from architecture, embedded systems, and cloud integration through V&V and audit-ready DHF assembly.
IEC 62304ISO 14971
Explore serviceIEC 62304ISO 14971FDA SaMD21 CFR Part 820
Engineering Where Precision
Is Non-Negotiable
We build IEC 62304-compliant medical device software and AI-driven healthcare systems that reach market faster — without compromising safety or regulatory integrity.
20+ years · IEC 62304 native · Class I–III devices · FDA SaMD aligned
- 20+Years in Medical Device Engineering
- IEC 62304Native Software Process
- Class I–IIIFull Device Coverage
- AI + FDAAligned Innovation
What We Do
One Partner. Every Stage of Development.
From IEC 62304-compliant software engineering to FDA-aligned AI/ML systems — we cover the full technical and regulatory lifecycle so you don't have to stitch together multiple vendors.
AI Healthcare Solutions
FDA-aligned AI/ML SaMD development, clinical decision support systems, and Predetermined Change Control Plan documentation that keeps your model update pipeline compliant.
FDA AI/ML 2021SaMD Class II
Explore serviceRegulatory Compliance
End-to-end 510(k) preparation, ISO 14971 risk management, Quality System Regulation documentation, and Design History File assembly — built in from day one, not bolted on at the end.
FDA 510(k)21 CFR Part 820
Explore serviceEnd-to-End Product Development
From concept to cleared product — connected medical devices, cloud health data platforms, IoT architectures, and legacy system modernization with full regulatory traceability.
IEC 62443HIPAA
Explore serviceAI Healthcare Solutions
AI That's Built for Regulatory Reality
FDA-aligned AI/ML SaMD development isn't just about model accuracy — it's about documentation, traceability, and change control from day one.
- FDA AI/ML Software as a Medical Device (SaMD) framework alignment
- Clinical Decision Support systems with explainability documentation
- Predetermined Change Control Plans for continuous learning models
- Post-market surveillance protocols for deployed AI systems
AI/ML SaMD Compliance Stack
Software ClassIEC 62304 Class C
FDA PathwayDe Novo / 510(k)
PCCP StatusDocumented
V&V FrameworkComplete
DHF AssemblyAudit-Ready
- FDA AI/ML Guidance 2021 Aligned
- Predetermined Change Control Plan
- Post-Market Surveillance Protocol
- Human-AI Interface Assessment
All compliance checkpoints active
Regulatory Expertise
Compliance Built In, Not Bolted On
We work inside the standards every day. IEC 62304, ISO 14971, FDA 510(k), and QSR aren't checklists we hand off at the end — they're the architecture of every engagement.
IEC 62304Software Lifecycle
Medical Device Software
Every line of code is traced through a documented lifecycle — requirements, architecture, unit testing, and integration — structured to satisfy Class A, B, and C classification requirements.
Class AClass BClass C
Learn moreISO 14971Device Risk
Risk Management
Risk management is not a deliverable we produce at the end — it's a living artifact updated throughout design, development, and V&V. Hazard analysis, risk controls, and residual risk acceptance built in.
Risk FileFMEAResidual Risk
Learn moreFDA 510(k)Market Clearance
Premarket Notification
Predicate device selection, substantial equivalence argumentation, and technical documentation structured to the FDA's submission guidance — audit-ready from day one.
Substantial Equiv.Technical FileeCopy
Learn more21 CFR Part 820QMS + HIPAA
Quality System Regulation
Quality Management System documentation, Design History File assembly, and HIPAA-compliant data architecture for connected health platforms — integrated, not siloed.
DHFDMRHIPAA
Learn moreDevelopment Lifecycle
From Concept to Cleared.
Five disciplined phases that take your device from idea to market — with every regulatory artifact built in at the right moment, never retrofitted.
- 01
Discovery
Device Classification & Risk Stratification
IEC 62304 software class determination, predicate device analysis, and initial risk file setup aligned to ISO 14971.
- 02
Architecture
System Design & Traceability Matrix
Software requirements specification, architecture design, and bidirectional traceability from requirements through test cases.
- 03
Development
Compliant SDLC Execution
Agile sprints with IEC 62304 unit of implementation gates — code reviews, unit tests, and hazard-linked change control at every merge.
- 04
Validation
V&V and Usability Engineering
System-level testing, IEC 62366 usability evaluation, cybersecurity testing (IEC 62443), and independent audit review.
- 05
Submission
DHF Assembly & Regulatory Filing
Audit-ready Design History File, 510(k) or De Novo submission package, and ongoing post-market surveillance setup.
Why Choose MTS
What Makes the Difference
Every medical device consultancy says they understand compliance. We built our practice around it.
Regulatory-First Engineering
We don't add compliance at the end. IEC 62304 process discipline, risk traceability, and DHF structure are the foundation of how we write code — not a layer applied afterward.
Every sprint closes with documented evidence. Every merge links to a requirement. Every test case maps to a risk control.
20+ Years of Medical Device Depth
Two decades of experience across Class I, II, and III devices means we've seen what fails in audit and what clears — and we build your product with that institutional knowledge baked in.
Embedded systems, cloud platforms, AI/ML pipelines, legacy modernization — we've shipped all of it under regulatory scrutiny.
One Partner. No Handoff Risk.
Software engineering, AI/ML development, risk management, and regulatory submission preparation all under one roof. No translation loss between vendors. No version control disputes.
From architecture kick-off to 510(k) eCopy, your technical and regulatory artifacts are produced by the same team.
Track Record
Results That Speak to Regulators
Two decades of shipping medical device software under regulatory scrutiny — the numbers reflect our depth, not our marketing.
0+
Years in Medical Device Engineering
Class I, II & III device programs
>0%
First-Cycle Clearance Rate
For 510(k) submissions we prepare
0+
Cleared & Approved Devices
Across software, AI/ML, and connected health
0%
Audit-Ready DHF Delivery
Design history files built from day one
Let's Build Something That Clears
Ready to Ship a Device That Survives Regulatory Scrutiny?
Tell us where you are in the development process. We'll identify the gaps, map the compliance path, and give you an honest assessment — in one call.
- No engagement commitments in the first call
- Senior engineers on every project — no bait-and-switch
- Regulatory expertise included, not add-on priced
20+ years · IEC 62304 native · Class I–III · FDA SaMD aligned