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.
- 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 3rd party validation of cybersecurity requirements.
- Analysis and evaluation of current ISO 14971 risk management procedures.
