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FDA Compliance

FDA Compliance

DHS is uniquely positioned to help your company navigate the 2023 FDA guidance for Cybersecurity in Medical Devices. Our team can provide a roadmap to make your product compliant with the latest expectations of the FDA to ensure a smooth submission process.



In addition to performing the traditional safety risk assessment per ISO 14971, cybersecurity failure modes and effects analysis (cFMEA) should be performed on any connected software medical devices. DHS can provide a team to perform this cFMEA for your product to identify any security risks and implement risk controls to enhance your device’s cybersecurity.



An important aspect of providing secure medical devices is creating and maintaining an up-to-date Software Bill of Materials (SBOM). DHS can help you create a comprehensive SBOM and develop a plan for post market surveillance for monitoring the items on the SBOM to ensure the cybersecurity of your device throughout its product lifecycle.

Penetration testing

Penetration Testing

DHS offers the skills to help perform penetration testing for your software product. This testing helps to provide vulnerability identification, evaluate the product's resiliency, give inputs for risk management, and stay compliant with the FDA's expectations for cybersecurity.

Threat modeling

Threat Modeling

DHS can offer a threat modeling strategy fit to your specific product. There are many ways to conduct threat modeling and we can help guide your team to the most effective strategy to develop a secure product.

Vulnerability scanning

Vulnerability Scanning

Vulnerability scanning is a fundamental cybersecurity practice employed to proactively identify and assess potential security weaknesses and vulnerabilities. DHS can help your team identify
the best tools fit for your needs to scan your software and associated systems.

Postmarket  ​surveillance

Post Market

After your connected healthcare solutions have been deployed, for business as well as regulatory reasons, your responsibilities include post-market surveillance for cyber security vulnerabilities. In today's world, most software running on cloud platforms includes combination of proprietary, third party and open source software.

Developing a software bill of materials using advanced tools and then periodic monitoring of the open source software for changing vulnerability is a must have competency that DHS can help provide.

Digital Health Solutions vulnerability analysis will also provide analysis on mitigation needed and the implementation of the mitigations.

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