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 Inc.®, we offer a wide variety of services for medical devices 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 you for the entire life cycle, from the development of your product all the way to the regulatory submission to your notified body.


Our Cybersecurity Medical Device Services Include:

  • FDA cybersecuritySupporting cybersecurity aspects of design control using secure design principles for the entire Product Life Cycle.
  • Preforming 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 3rd 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.


We Encourage Device Manufacturers to:

  • 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.


Contact RCA for Medical Device Cybersecurity Services

When you’re looking for a medical device consulting firm for your cybersecurity, or want to better understand the relationship between healthcare and cybersecurity, you need a partner with extensive industry knowledge that will customize a solution to meet your needs. With a unique blend of industry experts and FDA veterans, the team at Regulatory Compliance Associates® Inc. is here to help.


Since 2000, we’ve worked with thousands of medical device companies like yours around the world to resolve regulatory, compliance, and quality throughout the entire product life cycle. Whether you’re a small startup or multinational corporation, we take your needs into account as our team of industry specialists tailors the ideal strategy for you.


For more information or to request an FDA consultant service for your medical device, use the form below to contact us today.

Our website uses cookies to give you the best possible experience.

By continuing to use this site, you agree to the use of cookies.