Medical Device Cybersecurity and Software as a Medical Device (SaMD) Consulting Services
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.
Software as a Medical Device (SaMD) and IEC 62304
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. Our experts can help with:
- Investigational Software Guidance
- Development Analysis & Support
- Medical Device Studies
- Regulatory Support
We provide a range of medical device Compliance Assurance Services, including:
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 info@rcainc.com.
