Regulatory, Quality & Testing Services
Consultancies, test labs, CROs and submission specialists that serve device startups. 4 companies listed.
Consultancy that handles premarket cybersecurity for device makers: penetration testing of hardware, firmware, apps and cloud, plus threat modeling, SBOMs and the documentation that goes into 510(k), De Novo and PMA submissions. Founded by Christian Espinosa.
Analyzes device firmware and binaries to generate SBOMs and find vulnerabilities, and automates the security evidence manufacturers file for FDA and other regulators. Serves medical device, automotive, energy and industrial makers.
Sells software and services that medical device manufacturers use to handle product security: SBOM and vulnerability management through Helm, encryption and key management through Guardian, plus threat modeling and premarket submission support.
Provides device cybersecurity services across the product lifecycle: threat modeling, penetration testing, SBOMs, vulnerability scanning and postmarket plans for regulatory submissions. In March 2026 it launched BRIDGE, a platform for passing security advisories from manufacturers to hospitals. Led by CEO Michelle Jump.
New clearances, funding rounds and regulatory moves for device founders. No noise, no login.
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