Medcrypt
All whitepapers

Whitepaper · November 11, 2024

CryptographyFDA Cybersecurity ReadinessRegulatorySoftware as a Medical Device (SaMD)

Meeting FDA Expectations for Cryptographic Security in Medical Devices

How to Design, Implement, and Validate Cryptography That Meets Regulatory Requirements

Open whitepaper PDF
Thumbnail for Meeting FDA Expectations for Cryptographic Security in Medical Devices

Executive summary

What this whitepaper covers

The FDA’s latest cybersecurity guidance sets a clear expectation: cryptography is a cornerstone of medical device security.

This whitepaper provides a deep dive into how medical device manufacturers (MDMs) can meet FDA expectations for cryptographic design and implementation, covering key principles such as authenticity, integrity, and confidentiality.

It explores the most common mistakes in cryptographic design, clarifies how FDA expectations align with NIST standards like FIPS 140-3 and SP 800-131A, and outlines practical best practices for developing compliant and secure medical devices.

A case study highlights how Medcrypt’s Guardian Platform helps manufacturers streamline cryptographic implementation and achieve FDA-ready compliance faster.

Why it matters

The regulatory and product context

Cryptography isn’t just about encryption. It’s about establishing trust.FDA guidance (Premarket Cybersecurity, September 2023) now explicitly requires that devices demonstrate secure cryptographic capabilities, including key generation, management, certificate provisioning, and lifecycle security controls. Yet, many manufacturers still rely on IT-style cryptography or outdated algorithms that fail to meet device-specific constraints. This paper helps manufacturers close that gap by explaining how to translate regulatory language into practical, auditable design decisions.

Key insights

What you’ll take away

  • FDA expects manufacturers to design, implement, and document cryptography as part of their SPDF.
  • Using “off-the-shelf” IT cryptography is often insufficient. Devices require domain-specific implementation.
  • Common pitfalls include key reuse, weak storage, and lack of lifecycle management.
  • Cryptographic functions should map directly to FDA’s three pillars: authenticity, integrity, and confidentiality.
  • Medcrypt’s Guardian Platform enables scalable, compliant cryptographic identity management and mutual authentication for connected medical devices.

Who should read this

  • Product security and engineering teams designing connected or cloud-enabled medical devices
  • Regulatory and quality professionals preparing cybersecurity documentation for FDA submissions
  • Executive leaders and program managers responsible for FDA readiness and compliance strategy
  • R&D architects and cryptography specialists developing secure communication and key management infrastructures
Open PDF

Related resources

Go deeper on the topics in this whitepaper with Medcrypt analysis and real device programs.

Know where you are in 1 hour.

Run the free check or talk to a human. Either way, you’ll get a clearer view of readiness without a paywall or lengthy sales call.

Check readiness