Medical device cybersecurity, from design to market and postmarket
Security engineering, penetration testing, and regulatory evidence for the U.S., EU, and UK.
The Product Security Guild helps medical device and component manufacturers build security into their products, test what matters, and prepare defensible evidence for the markets they serve. From U.S. Food and Drug Administration (FDA) submissions to European Union (EU) and United Kingdom (UK) requirements, we connect hands-on cybersecurity expertise with product development and ongoing security management.
One security strategy. Multiple markets.
Different regulatory pathways bring different expectations. Your underlying cybersecurity work should be structured, traceable, and reusable wherever appropriate. Threat modeling, security testing, and vulnerability evidence can often serve multiple markets, while submission formats and regulatory expectations remain distinct. We identify shared evidence, map market-specific gaps, and help teams prepare for each review.
Regulatory readiness across your markets
FDA premarket cybersecurity & submission readiness
Support for cybersecurity gap assessments, risk documentation, testing evidence, and submissions using 510(k), De Novo, or Premarket Approval (PMA) pathways, as applicable. We help address FDA cybersecurity expectations, Section 524B considerations for cyber devices, and cybersecurity content within electronic Submission Template and Resource (eSTAR) packages.
EU MDR & IVDR cybersecurity support
Align security activities and technical documentation with applicable requirements of the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR). We support cybersecurity risk management, secure design evidence, verification, vulnerability management, and preparation for notified body questions and conformity assessment.
UK medical device cybersecurity support
Navigate applicable UK medical device requirements and Medicines and Healthcare products Regulatory Agency (MHRA) expectations, with attention to the differing rules for Great Britain and Northern Ireland. We help organize cybersecurity evidence, identify gaps, and support ongoing technical documentation and postmarket practices.
Technical cybersecurity services
Medical device threat modeling & security risk management
Identify attack surfaces and realistic threats, define security requirements, assess risks, and trace security controls to verification evidence. Connect cybersecurity decisions to product safety and the intended use environment.
Medical device penetration testing
Evaluate the complete device ecosystem with medical device penetration testing tailored to the product and threat model. Scoped testing can include embedded systems, firmware, hardware interfaces, Bluetooth Low Energy (BLE), radio frequency (RF) communications, wireless protocols, mobile applications, cloud connections, application programming interfaces (APIs), and integrated components. Findings support remediation and retesting.
Medical device SBOM & third-party component security
Develop and assess software bills of materials (SBOMs), examine software and firmware dependencies, analyze known vulnerabilities, and document component security assumptions. Build reusable security evidence that helps original equipment manufacturers (OEMs) evaluate the components they integrate.
Regulatory findings & cybersecurity deficiency response
Address FDA cybersecurity deficiencies, notified body findings, and other technical review questions through focused investigation, gap closure, remediation planning, testing, and updated evidence packages. We help teams respond with clear technical support, not generic compliance language.
Postmarket medical device cybersecurity
Support devices beyond clearance and market launch with postmarket vulnerability monitoring, exploitability and security-impact assessments, coordinated vulnerability disclosure, remediation and patch planning, change-impact analysis, updated software bills of materials, and ongoing security evidence maintenance.
Built for the products you make
From connected medical devices and software as a medical device (SaMD) to surgical robotics, medical imaging, laboratory instruments, wearables, implantable technologies, and critical embedded components, we tailor testing and documentation to product architecture, intended use, and destination markets.
Connected medical devices- SaMD
- Surgical robotics
- Medical imaging
- Laboratory instruments
- Wearables
- Implantable technologies
- Critical embedded components
Your timeline. The expertise you need.
Whether you need a complete cybersecurity workstream, a targeted firmware penetration test, an FDA deficiency response, or EU and UK regulatory evidence support, the Guild joins your team where specialist expertise makes the difference.
