Medical device security for manufacturers

Connect with us

Medical devices are vulnerable to security threats in the same way as other networked devices. This can affect safe and effective device operation and adversely impact patient care and safety. The Food and Drug Administration (FDA) provides guidelines for manufacturers to address cybersecurity risk as part of medical device design, development and deployment.

Mitigate medical device cybersecurity risk throughout the product life cycle

Cyber threats to medical devices have increased as these products are more frequently connected to hospital networks, the internet and other medical systems. There's a need for effective cybersecurity management to assure the functionality and safety of medical devices, and to protect connected networks. When a cyber incident is identified, manufacturers must have a transparent and well-developed disclosure program. Sensitive data is exposed when manufacturers conduct contracted maintenance and support of production devices or managed solutions. When a manufacturer is considered a business associate, they must adhere to HIPAA Security Rule requirements and healthcare delivery organizations’ vendor risk management programs.

Our Approach

Leveraging our healthcare and IoT expertise, we provide end-to-end medical device cybersecurity assurance services to help manufacturers go to market quickly and securely. Services include:

  • Cyber Risk Program Maturity Assessment
  • Cybersecurity Program, Policy & Procedure Development
  • Vulnerability Assessment and Penetration Testing
  • HIPAA Security Risk Analysis
  • Medical Device Cybersecurity Readiness Assessment
  • Medical Device Cybersecurity and Risk Management Advisory


  • Readiness assessment report with prioritized findings and recommendations
  • Workshop on medical device security, risk management and HIPAA compliance (optional)
  • Remediation roadmap

Medical Device Cybersecurity Readiness Assessment: Scope and Methodology

  • Customized security framework for manufacturers leveraging NIST 800-53, TIR-57, FDA pre- and post-market guidance
  • Product security policy and procendure review
  • Product risk assessment processes, MDS2 management
  • Secure development practices (securing code, code review, etc.)
  • Security technology usage in products (secure architecture, encryption, PKI, blockchain, hardening, etc.)
  • Threats and vulnerability management and disclosure
  • Post-market cybersecurity management practices
  • Incident response process

Why choose Coalfire for medical device security services?

  • Industry-leading expertise in cyber risk and healthcare threat landscape
  • Coalfire consultants are part of several industry working groups to advance healthcare and medical device security. We understand medical devices and the medical device industry.
  • Experience conducting risk management for large healthcare and life sciences organizations
  • Thought leadership on security solutions for the healthcare industry

Additional healthcare security services

Contact us to improve your cybersecurity posture