Medical Device Cybersecurity

Medical Device Cybersecurity

BioReg experts advise on medical device cybersecurity questions and help medical device manufacturers to design and manufacture products that are safe, secure, and continually monitored against cyber risks.

Medical Device Cybersecurity has become a growing concern within the medical device industry as more connected medical devices are introduced on the market.
The increased connectivity means that the healthcare sector is more prone to cybersecurity risks.

New laws on cybersecurity such as MDCG 2019-16: Guidance on Cybersecurity for Medical Devices; IMDRF: Principles and Practices for Medical Device Cybersecurity; FDA Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions; AAMI TIR-57: Principles for Medical Device Security-Risk Management; ISO 14971-2019: Risk management to medical devices – are aimed to:

• To protect patient safety
• To avoid privacy fines under new GDPR
• To prevent disclosure of personal patient data and health information
• To reduce the possibility of reputational damage due to a breach

BioReg services can write the following cybersecurity documents based on Product and QMS information provided by the Company:

• Cybersecurity Risk Management Plan
• Cybersecurity Risk Management Report, which will include:
  o Threat modeling
  o Cybersecurity risk assessment
  o Software Bill of Materials (SBOM)
  o Vulnerability assessment and Software support
  o Security assessment of unresolved anomalies
  o Cybersecurity Traceability
• Tracking Measures and Metrics
• Security Architecture Views
• Cybersecurity Design controls
• Cybersecurity test plan
• Cybersecurity labeling

Our team can perform the required Cybersecurity testing, such as vulnerability testing (scan) and penetration testing (Pentest).

Frequently Asked Questions

Question: How detailed should the Risk Management Report be?

Response: A Risk Management Report should include details about a separate, parallel, and interconnected security risk management process. You are advised to follow Section V. A of the Premarket Cybersecurity Guidance such as that described in AAMI TIR57 (Principles for medical device security – Risk management), which includes the following:

• Risk analysis, mitigations, and design considerations pertaining to cybersecurity risks
• A traceability matrix of security risks
• Traceability to the certification reports for documented security controls
• A description of when and how security updates/patches will be provided, and
• A description of the steps taken to assure devices will be delivered malware free
• And more

The companies should review FDA Cybersecurity Guidance – Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions.