Cybersecurity Testing, Compliance & Advisory for Connected and Regulated Products
From medical devices facing FDA Section 524B to industrial systems under IEC 62443 and products entering the EU under the Cyber Resilience Act, security is now a condition of market access.
- Lead with Medical Device Security: FDA Section 524B, IEC 81001-5-1, and SBOM — built on our FDA and IEC 60601 experience.
- Meet Global Regulations: EU Cyber Resilience Act, IEC 62443, ETSI EN 303 645, and NIST SSDF.
- Prove Your Security Posture: ISO 27001 and ISO 42001 / NIST AI RMF advisory.
- Test with Accredited Experts: vulnerability assessment, penetration testing, and fuzz testing — ISO 17025-accredited.
*Tell us about your product and target markets. A lead engineer will respond within one business day.
Trusted by Industry Leaders
The team was easy to communicate with, quick to respond, and truly committed to our success. Marty, Vic , Soliman, and even the accounting team provided us with white glove service. Not to mention that their facility is truly impressive!
We wouldn’t hesitate to work with them again, in fact we are looking forward to it!
The Challenge: Security Is Now a Condition of Market Access
Every connected product—from a consumer device to a Class II medical device or industrial machinery—now faces cybersecurity requirements as binding as safety or EMC. The EU CRA’s vulnerability-reporting obligations begin September 2026, FDA’s updated Section 524B guidance is already in force, and buyers expect proof of a real security program. One unaddressed vulnerability can mean a rejected submission, blocked market access, a costly recall, and reputational damage.
Five Service Areas, One Accredited Partner
Five service areas, organized around the regulations your product actually faces:
Pass FDA Review the First Time. FDA Section 524B readiness, IEC 81001-5-1 compliance, and a complete SBOM — built on our FDA and IEC 60601 experience.
Meet the CRA Before the Deadline. Vulnerability-reporting obligations begin September 2026 — gap assessment, SBOM, and conformity support to get there.
Test Like a Real Attacker Would. Penetration testing, IEC 62443 risk assessment, and ETSI EN 303 645 compliance for connected and industrial products.
Build Security In, Not Bolted On. NIST SSDF (SP 800-218) implementation and SBOM tooling to satisfy FDA 524B and CRA secure-by-design expectations.
Prove Your Security Posture. ISO/IEC 27001 information-security management and ISO/IEC 42001 / NIST AI RMF advisory for organizations adopting AI.