Cybersecurity In Medical Devices

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 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 medical device companies for the entire life cycle, including from the development of your product to the regulatory submission to your notified body.


FDA Cybersecurity Medical Device Services


  • Supporting cybersecurity aspects of design control using secure design principles for the entire Product Lifecycle.
  • 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.


FDA 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.


Medical Device Cybersecurity Consulting


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 industry knowledge who can customize a compliant solution. 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 around the world to accelerate regulatory, compliance, and quality throughout the entire product life cycle. Whether you’re a small medical instruments startup or multinational oxygen saturation monitor corporation, we take your individual needs into account.


IEC 62304


Software as a medical device can help patients self-manage their care without providing specific treatment or treatment suggestions. RCA’s design controls and DevOps team can help you save time for health care providers by automating repetitive tasks or common work. Our global network of experts can provide your team with engineering consulting in software design, development, cybersecurity, test systems, and manufacturing systems. That helps keep your team and medical devices in compliance with IEC 62304 and current FDA guidance.


  • Investigational Software Guidance
    • Device Exemptions
  • Development Analysis & Support
    • Mobile Platform
    • Mobile Application
      • Attachments
      • Display screens
      • Sensors
    • Mobile Medical Application
      • Accessories to a regulated medical device
        • Patient-specific analysis
        • Patient-specific diagnosis
      • Mobile platforms transformed into a regulated medical device
        • 21 CFR 803 Medical Device Reporting
        • 21 CFR 806 Corrections and Removals
        • 21 CFR 807 Premarket Notification
        • 21 CFR 820 Quality System
  • Device classification
    • Class I
      • General controls
    • Class II
      • Special controls in addition to general controls
    • Class III
      • Premarket approval
  • Medical Device Studies
    • Intended Use
      • Significant Risk (SR)
      • Non-significant Risk (NSR)


About Regulatory Compliance Associates


Regulatory Compliance Associates® (RCA) provides healthcare consulting services to the following industries for resolution of compliance and regulatory challenges:



We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.


As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.


  • Founded in 2000
  • Headquartered in Wisconsin (USA)
  • Expertise backed by over 500 industry subject matter experts
  • Acquired by Sotera Health in 2021


About Sotera Health


The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.


Sotera Health Company, along with its three best-in-class businesses – Sterigenics®Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.


We are a trusted partner to more than 5,800 customers in over 50 countries, including 40 of the top 50 medical device companies and 8 of the top 10 pharmaceutical companies.



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. 



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