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Cybersecurity

Cybersecurity Remediation

Cybersecurity Remediation

DHS offers a comprehensive audit of your medical device documentation to identify gaps in compliance with the latest FDA guidance for Cybersecurity in Medical Devices. DHS provides a roadmap to remediate any gaps identified. Additionally, DHS has a suite of services for ensuring your medical device meets all cybersecurity requirements.   

Secure Product Development

Secure Product Development

DHS provides a package of services designed to guide clients through a secure product development process. This service package includes detailed development methodologies, step-by-step procedural guidelines, and all necessary templates required for creating a cybersecurity submission package. This structured offering not only ensures a thorough approach to secure product development but also streamlines the process of preparing for cybersecurity submissions. 

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.

cFMEA

Security Risk Assessment

In addition to 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.

sBOM

SBOM

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.

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
Surveillance

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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