Consulting Services
Expert guidance for medical device cybersecurity.
Practical, no-nonsense consulting to help medical device manufacturers meet cybersecurity compliance requirements in the US, EU, and UK markets.
Our services
Regulatory Compliance
Navigate FDA premarket cybersecurity requirements, EU MDR Annex I, and MDCG guidance with confidence. Get practical advice tailored to your submission timeline.
Secure SDLC
Build security into your development process from the start. Implement IEC 81001-5-1 compliant SDLC practices that satisfy regulators and protect patients.
Gap Analysis & Remediation
Identify gaps in your current cybersecurity documentation and processes. Get a clear roadmap to compliance without the guesswork.
Team Training
Upskill your QA/RA and engineering teams on medical device cybersecurity requirements. Practical workshops focused on what regulators actually expect.
Regulatory markets we support
United States
FDA premarket cybersecurity guidance, 510(k) and De Novo submissions
European Union
MDR Annex I cybersecurity requirements, MDCG 2019-16 compliance
United Kingdom
UKCA marking, MHRA cybersecurity expectations
Please note: We focus on compliance consulting and secure development practices. We do not offer penetration testing or security assessment services.
Book a consultation
Schedule a free 30-minute discovery call to discuss your cybersecurity compliance challenges and how we can help.