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Technical Perspectives

Engineering Clarity in a Regulated World

Practical perspectives on IEC 62304, FDA SaMD guidance, AI/ML regulation, and the engineering practices that separate teams that ship from teams that stall.

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Regulatory shifts, AI governance, architecture decisions — the topics our clients navigate every day.

6 min read

AI/ML · Regulatory Strategy

Why Generative AI Is a Win for MedTech — If You Build the Right Governance

AI tools are transforming how medical device teams handle documentation, testing, and design. But in a regulated environment, the question isn't whether to adopt AI — it's how to govern it. Learn how MTS helps teams implement generative AI within a compliant IEC 62304 and FDA SaMD framework, turning policy into a competitive accelerator rather than a bottleneck.

AI/MLIEC 62304FDA SaMDDocumentation
May 12, 2026Full article coming soon
5 min read

Cybersecurity · Risk Management

Connected Devices: Why Perimeter Security Alone Won't Protect Your SaMD

Recent high-profile breaches have shown that network perimeters are no longer reliable protection for connected medical devices. Manufacturers must architect security from the inside out — embedding threat modeling and vulnerability management directly into the IEC 62304 software development lifecycle. MTS explains the integrated approach aligned with FDA SaMD guidance and ISO 14971 risk management.

CybersecurityISO 14971Connected DevicesRisk Management
April 8, 2026Full article coming soon
7 min read

Industry Insights · Market Analysis

2026 Medical Device Industry Outlook: Regulatory Preparedness as a Competitive Edge

Medical device manufacturers enter 2026 cautiously optimistic — but regulatory complexity, AI integration demands, and evolving FDA guidance are reshaping the playing field. Organizations that treat compliance as a design constraint rather than an afterthought are gaining time-to-market advantages their competitors can't easily replicate. Here's how MTS sees the landscape unfolding.

Industry TrendsFDA GuidanceAI/ML Regulation510(k)
February 5, 2026Full article coming soon

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More Technical Content in Progress

We're publishing in-depth guides on IEC 62304 lifecycle practices, FDA AI/ML submissions, and DevOps for regulated software teams. In the meantime, reach out directly — we're happy to answer your specific technical questions.

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