Overview
Cybersecurity & Compliance Services
MavenRS supports organizations in regulated industries such as healthcare, pharmaceuticals, life sciences, biotechnology, and critical infrastructure. We help clients achieve regulatory compliance, build cyber-resilient digital foundations, and maintain continuous audit readiness through specialized cybersecurity consulting and compliance services.
Regulatory Resilience
- Risk acceptance criteria and residual risk assessment matrix
- Control mapping and regulatory evidence documentation
- Policy development tailored to regulatory submissions (FDA, EMA, MHRA, IVDR)
Client benefits:
- Reduced audit risk and fewer compliance gaps
- Faster regulatory approvals, inspections, and certifications
- Stronger data governance, patient safety, and digital trust
Secure Product Development
We integrate secure-by-design, DevSecOps, and regulatory cybersecurity frameworks into the entire product lifecycle, ensuring security and compliance embedded from concept to post-market.
- Threat modeling and attack surface analysis for medical devices and digital health platforms
- Secure design reviews aligned with ISO 27034 & IEC 62443
- SBOM (Software Bill of Materials) automation with VEX (Vulnerability Exploitability eXchange)
- Continuous vulnerability management integrated with FDA 510(k), CE Marking, and IVDR submissions
Client benefits:
- Reduced cybersecurity risks in connected medical devices and IVDs
- Confidence in regulatory submissions with stronger security documentation
- Lower lifecycle costs by finding issues earlier in product development
Cloud & Infrastructure Security
We secure hybrid cloud, cloud-native environments, and connected IoT/medical ecosystems with regulatory-grade cybersecurity frameworks.
- Cloud platform configuration hardening and monitoring (AWS, Azure, GCP)
- Network and endpoint security hardening aligned with NIST 800-53
- Security controls for connected laboratories, IoMT devices, and critical digital health infrastructure
- Immutable logging & monitoring for audit-ready evidence
Client benefits:
- Resilient and compliant cloud infrastructure
- Protection of sensitive healthcare and patient data
- Demonstrable compliance with HIPAA, GDPR, ISO 27001, and SOC 2
AI & Digital Safety
We enable organizations to adopt AI in diagnostics, clinical workflows, and healthcare systems responsibly, ensuring AI governance and regulatory compliance.
- AI governance frameworks and risk assessment policies
- Ethical AI adoption guidelines aligned with EU AI Act & FDA AI/ML framework
- Operational guardrails for AI-enabled diagnostics and digital therapeutics
- Validation and audit readiness for AI/ML-driven medical devices
Client benefits:
- Safe and regulatory-compliant AI adoption
- Increased trust in AI-driven healthcare solutions
- Reduced risks of ethical, legal, and regulatory pitfalls
Operational Readiness
We prepare organizations to detect, respond, and recover from cyber incidents while maintaining regulatory inspection readiness.
- Incident response playbooks (ransomware, data breaches, insider threats)
- Independent penetration testing aligned with OWASP, NIST, ISO 27001, and FDA expectations
- Immutable logging & continuous monitoring dashboards
- KPI-driven compliance reporting for executives and regulators
Client benefits:
- Faster cyber incident detection and response
- Clear evidence of cyber maturity and compliance posture
- Continuous audit readiness & risk resilience
Why Choose MavenRS
By combining regulatory expertise, cybersecurity engineering, and industry best practices, MavenRS helps clients achieve regulatory compliance while reducing operational risks.
- Submission-ready for FDA 510(k), CE marking, IVDR, EMA approvals
- Audit-ready for HIPAA, GDPR, ISO 27001, SOC 2, and NIST frameworks
- Future-proof with digital resilience, cyber risk reduction, and compliance automation
MavenRS is your trusted partner for cybersecurity consulting, regulatory compliance, cloud security, AI governance, and audit readiness across healthcare, life sciences, pharmaceuticals, and critical infrastructure sectors.
