Medical device compliance
End-to-end consultancy for IEC 62304 and ISO 13485 compliance, streamlining CE marking, UKCA certification, and FDA approval readiness.
Secure by design | Privacy by design | AI-driven
SecTech Innovations LTD specialises in medical device consultancy and cybersecurity solutions, driving compliance and innovation with expertise in IEC 62304, IEC 81001-5-1, MDCG cybersecurity guidance, and GDPR.
Our expertise
End-to-end consultancy for IEC 62304 and ISO 13485 compliance, streamlining CE marking, UKCA certification, and FDA approval readiness.
Embed cybersecurity and privacy into product development with IEC 81001-5-1, IEC 62443, MDCG cybersecurity guidance, and GDPR awareness.
Development and consultancy for embedded systems, real-time operating systems, IoT integrations, and hardware-software optimisation.
Product
VigilySys helps medical device teams map product context to cybersecurity, privacy, usability, SBOM, and risk-control work packages for FDA, CE, UKCA, and buyer readiness.
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