WEBINAR

From CRA to FDA: Building Compliant Devices That Stay Compliant in the Field

June 16, 2026
1:00 PM (EST)

Most OEM teams have already done the hard work of getting devices connected and to market. What’s harder to maintain is what comes after — a provable, audit-ready compliance posture across a fleet that’s growing, aging, and operating under regulatory frameworks that don’t stand still.

As fleets scale and device lifecycles extend, the gap between “we think we’re compliant” and “we can demonstrate it to an auditor” widens. Certificate lifecycle management breaks down. OTA update integrity drifts. Runtime security posture goes unverified. And the devices shipped today are being designed against cryptographic standards that post-quantum computing will eventually make obsolete.

Join our panel of experts from DigiCert, Exein, and Mesh Systems as they walk through where connected device compliance actually breaks down in the field, what regulators are looking for when they show up, and what it takes to build a security architecture that holds up across the full device lifecycle.

Key Takeaways: 

  • Why compliance gaps in deployed fleets are harder to find — and more expensive to fix — than gaps caught at design time
  • What auditors are actually looking for beyond premarket certification, and where OEM teams consistently fall short
  • Why user-space security cannot solve a firmware-level problem, and what kernel-level enforcement catches that conventional monitoring misses
  • How to build certificate lifecycle management and OTA update integrity into your architecture before they become audit findings
  • What crypto-agility means in practice, and why the PQC migration window is an architectural decision you need to make now

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Our Panelists

Tim McCalister Headshot
Chris Lanier Headshot
Callie Kirby Headshot

Tim McCalister

Field CTO

DigiCert

Chris Lanier

Managing Director, Americas

Exein

Callie Kirby

Associate Technical Principal

Mesh Systems

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Learn how MeshInsights uses AI agents to turn connected product data into automated decisions that drive real operational outcomes.

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Key Takeaways

Below are the top takeaways from our webinar, “Launching is Just the Start: Ensuring Success After Your Connected Product is Deployed​”. Watch the above recording for details on each.

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