About MTS
20+ Years of Medical Device Engineering
MTS is a development firm specializing in software design, architecture, development, testing, and project management. We have over 20 years of experience in medical devices and many other platforms — providing qualified professionals to match the right candidate with the right experience for every project.
- 0+Years of ExperienceMedical device software engineering
- 0+Cleared DevicesClass I, II & III programs
- 0%First-Cycle ClearanceFDA 510(k) submissions
- 0%Audit-Ready DeliveryDHF built from day one
Our Mission
Empowering Teams with Tailored Solutions
At MTS, our mission is to empower businesses and organizations with innovative and tailored solutions that drive growth, efficiency, and success — while never compromising the safety, accuracy, and regulatory integrity that medical device development demands.
- Software design, architecture & development
- IEC 62304-compliant SDLC process management
- Medical device testing & V&V
- AI/ML SaMD development & documentation
- FDA 510(k) and regulatory submission support
- ISO 14971 risk management
- Project management for regulated programs
- Legacy system modernization
Compliance as Architecture
IEC 62304 process discipline, risk traceability, and DHF structure aren't deliverables we produce at the end — they're the foundation of how we write code.
Right Candidate, Right Project
We match professionals with the precise experience your project requires. Engineering depth meets domain-specific regulatory knowledge on every engagement.
Human-in-the-Loop, Always
Whether it's AI workflow automation or manual verification, every critical decision point involves qualified engineers — not automated rubber-stamping.
Full-Spectrum Capability
Software design, architecture, development, testing, and project management — across embedded systems, cloud platforms, and AI-driven healthcare applications.
Our History
Built on Two Decades of Domain Depth
Founded on Engineering Depth
MTS was established to fill a specific gap: medical device programs needed engineers who understood both the software craft and the regulatory environment. We built our practice around that intersection from day one.
Staffing the Right Candidate
MTS provides qualified professionals to help you in your upcoming projects, matching the right candidate with the right experience to meet your project deadlines — a model that has delivered across Class I, II, and III device programs.
AI-Enabled, Compliance-First
As the regulatory landscape evolves to address AI/ML in medical devices, MTS is already building to the FDA's AI/ML guidance — delivering SaMD development and Predetermined Change Control Plans that keep innovation moving forward without regulatory exposure.
Our Staff
Senior Engineers on Every Engagement
No bait-and-switch. The engineers you meet in the discovery call are the engineers who work on your device. Our team brings 20+ years of hands-on experience in medical device software across embedded systems, cloud platforms, and AI pipelines.
Software Engineers
IEC 62304-trained engineers across embedded C/C++, Python, cloud, and mobile platforms.
Regulatory Specialists
510(k) preparation, ISO 14971 risk files, DHF assembly, and QSR documentation experts.
Project Leadership
Program managers who understand both Agile delivery and the compliance gates that govern medical device development.
Interested in joining the MTS team?
We work with experienced medical device and software engineers. Reach out to discuss open opportunities.
Ready to Work with a Team That Knows Medical Device Software?
Tell us about your project — device class, development stage, and regulatory pathway. We'll map the right team and compliance structure to get you to market.