How Medcrypt's Guardian Helps Medical Device Manufacturers Prepare for the Post-Quantum Future

Topics:

All authors

July 21, 2025

How Medcrypt's Guardian Helps Medical Device Manufacturers Prepare for the Post-Quantum Future

In this series, we’ve explored why post-quantum cryptography (PQC) matters, what regulators expect, and why crypto agility requires more than a patch. Now let’s see how a real-world team put planning to the test - and how Medcrypt’s Guardian platform could have saved them from a last-minute scramble.

A Cautionary Tale: The Q1 2026 Submission Crunch

A global medical device imaging company aimed to freeze their codebase in Q3 2025 - three weeks ago - to prepare for their FDA submission window in Q1 2026. Only after code-freeze did they realize their chosen Elliptical Curve Cryptography (ECC) curve was slated for deprecation in NIST’s upcoming PQC roadmap. With no agility plan in place, they now face weeks of redesign, recertification testing, and supplier negotiations just to swap algorithms - risking a delayed submission and ballooning validation costs.

What Guardian Is

Guardian is more than “lifecycle management” - it’s your crypto governance and agility platform, tailored for medical devices. It gives you

Design-time crypto mapping

A product-version matrix showing which algorithms, key lengths, certificates and secure elements are built into each firmware release and device model.

Field-deployment visibility

A live registry of which physical devices (by serial, model, firmware build) are out in the world and exactly what crypto they’re running today.

Policy-driven controls

Centralized rules for algorithm usage, key rotation schedules, and update approvals, enforced across R&D, QA, and manufacturing teams.

PQC-ready workflows

Guided templates for identifying where post-quantum swaps are needed, staging new algorithms in a sandbox, and rolling them out with full audit trails.

Why it matters: without both design-time and field-device views, you can’t target updates accurately - and as this global medical device imaging company discovered, missing that gap can grind your regulatory timeline to a halt.

What Guardian Helps You Do

Map Every Crypto Configuration

For example, you can see “version 123” uses RSA-2048 for TLS and ECC-256 for firmware signing, while “version 124” was upgraded to ECC-384 - and you’ll be able to track which deployed units are eligible for this update.

Track Certificates and Keys in Flight

Automatically flag expiring certs, orphaned keys, or untracked secure elements before they become field-failures or audit findings.

Enforce Crypto Policies

Set your minimum key-length, forbid legacy curves, mandate PQC-experiment flags - then get real-time alerts when a build strays.

Stage PQC Migrations

From sandbox testing through staged roll-outs, leverage built-in workflows for deploying NIST-approved PQC primitives as standards evolve.

Real-World Scenarios Guardian Supports

New device launches - build future-proof crypto into your roadmap, not retrofit it later.
Inherited legacy products - discover unknown or undocumented crypto and remediate gaps.
FDA submissions - produce ready-to-present crypto-posture reports and “update plan” artifacts.
Executive briefings - demonstrate traceable, future-ready crypto for customers, auditors, and regulators.

Why This Matters Now

NIST’s PQC standards are final. The clock’s ticking on curves you rely on today
FDA demands “reasonable assurance.” Section 524B and Premarket Guidance expect crypto-update roadmaps.
Manual patches cost millions. Without agility, every algorithm swap triggers full re-validation and field support nightmares.

Preparing for cryptographic change isn’t a distant project - it’s a current compliance and design priority.

‍