Customer Persona

Medical device & life sciences

Medical device manufacturer or life sciences company under FDA premarket cybersecurity guidance and EU MDR / IVDR.

Other Personas
FDA
SBOM-ready submissions
EU MDR
Coverage built-in
Postmarket
VEX automation

Company shape

  • Class II or Class III device with software
  • FDA premarket submission in the next 12 months
  • EU MDR / IVDR scope, EU CRA on the horizon
  • Quality / regulatory function with explicit SBOM mandate

Buying signals

  • Recent FDA refusal-to-accept letter mentioning SBOM
  • Quality team hiring "product cybersecurity"
  • Public 510(k) submissions with cybersecurity sections
  • Pen-test report attached to last submission

What today looks like.

FDA wants CycloneDX/SPDX SBOM per device version — current tool exports JSON-of-the-month

Postmarket vuln management is ad-hoc

Quality team operates in change-controlled environment; AppSec tools assume the opposite

Why Safeguard fits.

SBOM Studio outputs CycloneDX 1.6 + SPDX 3.0 ready for FDA submissions

VEX management for postmarket vulnerability disclosure

Auditable build provenance (SLSA L3+)

The product mix this Persona runs.

AI-native and traditional, in the rhythm that fits.

AI-Native
Griffin AIAI-BOM
Traditional
SBOM StudioVEXScanner SuiteSecure ContainersSLSA Provenance

Personas who lead the buy.

The people in this org who get the most out of Safeguard.

See Safeguard tailored to this Persona.

Book a 30-minute working session. We'll bring the product mix, benchmarks, and rollout plan tailored to this Persona's shape.