Medical Device Cybersecurity

For medical device manufacturers, technology can be a double-edged sword. The innovative technologies that elevate the quality of life for patients can also be used to potentially undermine the organization using the device. The consequences can affect the device itself if we do not implement good IoT cybersecurity and FDA cybersecurity protocols. At Regulatory Compliance Associates^®, we offer a wide variety of services for medical device security to help ensure that your product is protected from cyber-attacks.

With a well-planned design, along with full visibility of product development and the supply chain, RCA can help strengthen your device’s cybersecurity posture throughout. We partner with medical device companies for the entire life cycle, including from the development of your product to the regulatory submission to your notified body.

Cybersecurity Medical Device Services

• Supporting cybersecurity aspects of design control using secure design principles for the entire Product Lifecycle.
• Performing Gap analyses on your device’s current cyber resilience.
• Utilizing threat risk modeling to identify potential vulnerabilities or the absence of appropriate safeguards for future threats. 
• Generation of regulatory submission documentation per the FDA’s cybersecurity guidance, as well as the EUMDR MDCG 2019-16 cybersecurity guidance.
• Perform a cyber risk analysis to manage confidentiality, integrity, and availability and reduce attack surface area.
• Create a software bill of material for purchased components of the product to better manage vulnerabilities.
• Independent 3^rd party validation of cybersecurity requirements.
• Analysis and evaluation of current ISO 14971 risk management procedures.

Trustworthy Medical Device Cybersecurity

• Contains hardware, software, and/or programmable logic that is based on FDA cybersecurity guidance and regulatory standards.
• Provides a reasonable level of availability, reliability, and correct operation.
• Is reasonably suited to performing its intended functions.
• Adheres to generally accepted security procedures.

Cybersecurity Medical Device Best Practices

• Identify assets, threats, and vulnerabilities.
• Assess the impact of threats and vulnerabilities on the device’s safety and performance.
• Assess the likelihood of a threat as well as the likelihood of a vulnerability being exploited.
• Determine security risk levels and suitable mitigation strategies.
• Evaluate residual security risk and risk acceptance criteria.

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. You may also email us at [email protected].