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IEC 62304ISO 1497121 CFR Part 820HIPAAISO 13485

Solving Complex Problems with Strategic Solutions

Effective medical device development requires structured decision-making. MTS's consulting services are designed to define your business needs and identify the critical aspects of your product, process, and organization — so you build the right thing, the right way, the first time.

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What We Offer

Five Consulting Disciplines, One Experienced Team

From product strategy and architecture review to program rescue — we bring 20+ years of medical device domain knowledge to every engagement.

01
Product StrategyRegulatory PathwayPortfolio Planning

Product Roadmapping

MTS assesses your business needs, competitive landscape, and existing or planned medical device products to develop an effective investment strategy and compliant product portfolio plan — including regulatory pathway selection, device classification, and submission timeline.

  • Business needs and intended use analysis
  • Regulatory pathway and device classification strategy
  • Portfolio prioritization with compliance milestone mapping
  • Predicate device landscape and competitive positioning
02
IEC 62304Architecture ReviewSOUP

Architecture Assessment

MTS evaluates your existing or planned software architecture against IEC 62304 requirements, critical business constraints, and safety objectives — ensuring design and technology choices that support both your product goals and your regulatory submission.

  • IEC 62304 architecture review against software class requirements
  • SOUP identification, evaluation, and documentation gaps
  • Interface design and component boundary analysis
  • Technology stack suitability for regulated environments
03
DevOpsSDLCQMSCI/CD

DevOps Assessment

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

  • SDLC toolchain evaluation against IEC 62304 process requirements
  • CI/CD pipeline review for regulated software environments
  • Change control and configuration management gap analysis
  • QMS alignment with ISO 13485 and 21 CFR Part 820
04
CloudHIPAAIEC 62443Migration

Cloud Migration Assessment

MTS evaluates the suitability of public cloud and SaaS components for your medical device or health platform — identifying HIPAA-compliant architecture decisions, vendor selections, organizational changes, and an adoption roadmap that preserves regulatory traceability.

  • HIPAA-compliant cloud architecture evaluation
  • Vendor and SaaS component risk assessment
  • Data residency, audit logging, and access control planning
  • Migration roadmap with regulatory documentation continuity
05
Program RescueGap AnalysisDHF Audit

Program Health Assessment & Remediation

MTS evaluates your in-progress medical device development program — identifying critical risks, compliance gaps, and schedule impediments, and establishing a prioritized remediation plan to get back on track before they become submission blockers.

  • IEC 62304 and ISO 14971 compliance gap identification
  • DHF completeness audit and documentation triage
  • Schedule risk analysis and critical path remediation
  • Regulatory submission readiness assessment

Our Approach

Define It Right. Build It Once.

Every consulting engagement ends with a concrete, prioritized action plan — not a report. We identify what to fix, in what order, and how to close the gap before it becomes a submission blocker.

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  • Define before you build

    Effective product development requires structured decision-making. We identify the critical aspects of your product, process, and organization before a line of code is written.

  • Medical device domain expertise

    Our consultants have shipped Class I, II, and III devices. We know which architectural decisions create regulatory debt — and which ones clear review the first time.

  • Actionable, not theoretical

    Every assessment ends with a concrete remediation plan, not a slide deck of observations. You leave knowing exactly what to fix and in what order.

  • Integrated with your team

    We work alongside your existing engineers and regulatory staff — transferring knowledge, not creating dependency. You own the outcome.

When to Engage MTS Consulting

The Right Time Is Earlier Than You Think

Starting a new device program

Get the regulatory pathway, architecture, and toolchain right before a single line of code is committed.

Inheriting a legacy system

Understand what you actually have — compliance gaps, SOUP risks, architecture debt — before you modernize.

Preparing for a 510(k) submission

A program health and DHF readiness audit surfaces documentation gaps while there's still time to close them.

Moving to the cloud

Ensure your cloud migration strategy is HIPAA-compliant and that traceability doesn't break in transit.

Scaling your dev team rapidly

A DevOps and SDLC assessment ensures new engineers inherit a process that produces compliant artifacts.

Program is off track

A program health assessment identifies the critical path back to compliance and schedule before the situation becomes unrecoverable.

Contact Us Today to Discuss How We Can Help

Tell us where you are — new program, legacy system, or off-track delivery. We'll identify the highest-leverage consulting engagement and get you moving.

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