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IEC 62304ISO 14971IEC 62443HIPAA21 CFR Part 820

From Concept to Life-Changing Solutions

MTS's multi-disciplinary product development teams take ownership of all or part of your development effort — tailoring our process to accelerate your product to market with quality, compliance, and budget intact.

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What We Do

Five Disciplines, One Accountable Team

We tailor our engagement to what your program needs — full ownership or targeted support for a specific phase.

Step 01
Product DefinitionIntended UseRegulatory Strategy

Product Definition & Planning

MTS refines your product definition, ensuring clarity of user needs, intended use, and regulatory classification. We map out development stages, milestones, and the documentation structure required for a successful 510(k) or De Novo submission.

  • User needs analysis and intended use documentation
  • IEC 62304 software classification and risk stratification
  • Development roadmap with regulatory milestone gates
  • Predicate device analysis and pathway selection
Step 02
IEC 62304SaMDEmbeddedCloud

Software Development

MTS supports the full software lifecycle — from requirements definition, risk assessment, and UX design through architecture, detailed design, and implementation. We cover embedded, mobile, web, cloud, and SaMD platforms under a single IEC 62304-compliant process.

  • Software Requirements Specification and architecture design
  • Embedded C/C++, cloud-native, mobile, and web development
  • AI/ML SaMD development with PCCP documentation
  • IEC 62304-compliant SDLC with full traceability
Step 03
V&VIEC 62366Test Reports

Design Verification & Validation

MTS conducts design verification — ensuring every software requirement is fully met — and design validation, ensuring the design satisfies user needs and intended use. Every test case traces to a requirement; every requirement traces to a risk control.

  • System-level V&V against the full requirements specification
  • IEC 62366 usability engineering and summative evaluation
  • Independent V&V review and anomaly resolution
  • Audit-ready test reports for FDA submission
Step 04
IoTHIPAAIEC 62443Cloud

IoT & Connected Device Architecture

MTS designs and implements connected medical device ecosystems — secure cloud data platforms, IoT device communication layers, and companion mobile applications — with HIPAA-compliant data handling and IEC 62443-aligned security architecture built in.

  • Cloud health data platform design and implementation
  • Secure device-to-cloud communication architecture
  • HIPAA-compliant data handling and audit logging
  • Legacy system modernization with regulatory traceability
Step 05
QMSProcess ImprovementToolchain

Development Process, Procedures & Tools

MTS evaluates your current tools and processes supporting the software lifecycle, identifying opportunities to streamline engineering, reduce compliance overhead, and generate more value — without sacrificing the traceability regulators require.

  • SDLC toolchain evaluation and optimization
  • QMS gap assessment against IEC 62304 and ISO 13485
  • CI/CD pipeline configuration for regulated environments
  • Team training and process documentation

How We Engage

Full Ownership or Targeted Support

We tailor our involvement to what your program actually needs — from taking on the entire development effort to integrating with your existing team for a specific phase.

Discuss Your Project

  • Full program ownership

    MTS takes end-to-end responsibility — from product definition through 510(k) submission. One team, one contract, one accountable point of contact.

  • Targeted engagement

    Need help with one phase? We integrate with your existing team and tools to fill specific gaps without disrupting your process.

  • Regulatory embedded by design

    Every sprint closes with compliant documentation. DHF artifacts are built in real time — not assembled in a panic before submission.

  • Scalable to your device class

    Class I software utility to Class III AI-driven diagnostic — the same rigorous process, scaled to the actual risk profile of your device.

Connected Medical Devices

IoT device architecture, secure firmware, and HIPAA-compliant cloud backends — designed and delivered under a single regulatory process.

IoTIEC 62443HIPAA

Cloud Health Data Platforms

Scalable cloud infrastructure for health data ingestion, processing, and reporting — with audit logging and access controls aligned to healthcare data regulations.

CloudHIPAAHL7/FHIR

Legacy System Modernization

Migrating aging device software to modern platforms without losing regulatory history — traceability maintained, DHF updated, no documentation debt carried forward.

ModernizationIEC 62304DHF

Ready to Bring Your Device to Market?

Contact MTS today to discuss how we can accelerate your product development — whether you need a full-program partner or targeted expertise for a specific phase.

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