Many medical devices today are connected to provider networks. And while that offers benefits to patients and healthcare providers, it also enables the possibility of cybersecurity attacks.
Organizational Cybersecurity Governance and Quality System Integration
Battelle can assist you in implementing an overarching medical device cybersecurity program to support total product lifecycle in accordance with current security guidance from various regulatory agencies.
Risk Management Framework (RMF) Compliance
Battelle can assist you in applying the RMF to your medical device design. By navigating the federal IT security requirements to identify what is required for your medical
device, Battelle can help develop a product design and documentation suite consistent with these requirements. If you would like to sell to the VA/DoD, then RMF compliance is mandatory.
FIPS 140-2 Compliance
Battelle can assist you in navigating the FIPS 140-2 requirements to identify what will be required for your product by government customers and in developing a cryptographic architecture consistent with government requirements.
FDA Pre- and Post-Market Support
Battelle can assist you at any stage of the product lifecycle to meet FDA pre- and post-market cybersecurity requirements.
Ready to secure your medical devices?
Contact us today for a customized solution.