Cybersecurity for Medical Devices: Ensuring MDR Compliance & Secure Development Across the Entire Lifecycle
Cybersecurity across the entire lifecycle of medical devices – in compliance with MDR, MDCG 2019-16, IEC 62304, IEC 81001-5-1, and CRA.
Cybersecurity für Medizinprodukte: Live-Vortrag
Sicherheit über den gesamten Lebenszyklus von Medizinprodukten — Anforderungen, Praxis und audit-fähige Umsetzung.
Patient Safety Begins with Digital Security
Cybersecurity risks can directly translate into patient safety risks. Per MDCG 2019-16, cybersecurity risks in medical devices are an integral part of risk management as they can directly impact patient safety. IT-related security incidents can evolve into safety-relevant risks when they impair device function or clinical performance, ultimately leading to patient harm.
VamiSec supports manufacturers in implementing cybersecurity requirements across the entire lifecycle – from Security-by-Design, SSDLC, and threat modeling through vulnerability management to post-market surveillance and audit-ready documentation in compliance with MDR and IVDR.
Implementation in 4 Phases
Baseline Assessment & Gap Validation
Based on a structured inventory, existing SOPs and evidence are compared against IEC 62304, IEC 81001-5-1, MDR, and MDCG guidelines. Identified gaps are prioritized and translated into a clear action plan.
Process Harmonization & Enhancement
Missing or incomplete processes are supplemented and harmonized with existing SOPs. Focus is on SSDLC, vulnerability and patch management, and regulatory-compliant documentation.
Operational Implementation & Evidence Generation
Defined processes are operationally embedded and supported by suitable tools. Security activities and decisions are documented traceably and with audit-proof evidence.
Audit Readiness & Fine-Tuning
Documentation is consolidated, checked for consistency, and specifically prepared for audits. Remaining gaps are closed and internal reviews are conducted.
What We Do for You
Governance, Traceability & Audit Readiness
Integration of vulnerability and security monitoring activities into existing lifecycle, supplier, and post-market processes to ensure traceable decisions, measurable effectiveness, and audit-ready documentation in compliance with MDR and applicable standards.
Ensuring Security by Design
Establishing a systematic approach to managing cybersecurity risks throughout the entire component lifecycle, including risk assessment based on attack paths, threat scenarios, and risk mitigation strategies.
Secure Software Development Lifecycle
Integrating cybersecurity into the SDLC by defining security requirements, implementing secure coding practices, and ensuring continuous risk assessment through design, testing, and deployment.
Creating CI/CD Pipelines
CI/CD pipelines integrate SAST and SCA as defined quality gates, ensuring that code quality, security risks, and third-party dependencies are systematically assessed before release.
Vulnerability Lifecycle Management & Incident Response
Definition and documentation of a consistent approach for identifying, assessing, tracking, remediating, and accepting vulnerabilities across the entire product lifecycle, including legacy software, third-party software (SOUP), and supplier components.
Technical Documentation & SBOM
A Software Bill of Materials (SBOM) provides transparency and control over all software components used in medical devices. It forms a central foundation for vulnerability management, supply chain security, and regulatory conformity under MDR and the Cyber Resilience Act.
Frequently Asked Questions
Which medical devices are affected by the MDR?
All medical devices and in-vitro diagnostics marketed in the EU. Particularly relevant are connected devices (Software as a Medical Device – SaMD) and devices with communication interfaces.
What does MDCG 2019-16 require for cybersecurity?
The MDCG guideline requires Security-by-Design, threat modeling, penetration tests, secure updates, vulnerability management, and a post-market surveillance strategy across the entire product lifecycle.
How long does a cybersecurity assessment take?
Depending on the complexity of the medical device, between 4 and 12 weeks. We create a concrete timeline after a brief initial meeting.
Do you also support certification?
Yes. We support you from gap analysis to complete documentation for your notified body.
Protect Your Organization Now!
Contact us for an individual consultation and security solution tailored to your requirements.
Valeri Milke, CEO of VamiSec
"Only when all instruments are well-tuned does your organization become secure and compliant."