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Finding the right balance of security and solutions based of your company’s risk exposure. Companies come in all different sizes, product portfolio’s, IP, databases with PHI/PII and cybersecurity acuity. With over 1500 different cyber security providers, software solutions and consultants, finding a cost effective balance between expertise and maturity level of your company incredibly challenging.

We have partnered with the best and the brightest experts in the world that have been at the forefront of the Healthcare industry for:

  • Product Development & Deployment,
  • FDA Requirements,
  • Hospital Infrastructure
  • Hitrust,
  • NIST
  • GDPR And
  • Threat Modeling

At CYBRMD, our medical device cyber experts will help you overcome the burgeoning risk management, regulatory, and market demands current faced by the digital health arena.

How We Can Help

We are uniquely positioned to help you properly navigate the complex world of device security

Cyber Regulatory Support

At CYBRMD, we consult with device manufacturers and users to help mitigate cybersecurity, data privacy and interoperability risks and meet the abundant regulatory requirements.

  • Distribution Strategy
  • New Product Development
  • Commercialization

Medical Device Security Risk Assessment

We help provide management with a precise picture of cyber risk, along with recommendations on how to improve overall risk, and compliance of regulatory obligations.

  • Distribution Strategy
  • New Product Development
  • Commercialization

Compliance Advisory Services

We provide advisory and coordination support with key cybersecurity breach assessment, notification, and reporting requirements for each jurisdiction in which your organization operates. This specialized service helps you successfully navigate healthcare’s complex federal and state regulatory requirements.

  • Distribution Strategy
  • New Product Development
  • Commercialization

Compliance Assessments

We work with your team to evaluate the existing compliance protocols while providing meaningful feedback on the various elements and identified shortfalls. The assessment also offers insight into industry best-in-class practices that can improve the device.

  • Distribution Strategy
  • New Product Development
  • Commercialization

FAQ’s

Questions focus on our clients' most critical issues and opportunities.

No, just because you do not find anything does it indicate that the device is secure. You would be wise to understand that cyber security must be based on a well-structured, ongoing development process plus frequent tests.

No, there are no laws that require you to execute a test, however, most compliance documents and industry standard guidelines HIGHLY RECOMMEND that such a scan be considered.

You must consider security related tests to show that ANY change did not have a negative effect on the cyber security of your device. In most cases tests should be executed after any and all changes.

In theory, yes, you can however, you need to have the appropriate expertise within your organizational structure In our opinion, you should have an external resourcetest your devices.

The answer is simple — IMPARTIALITY. The strongest argument for having a 3rd party assessment is the impartiality of that provider.

We Welcome Complex, High-Stake Challenges

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