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Consulting Suite

Consulting services to help you conform to the cybersecurity pre-market regulations

Providing you with risk assessments considerations throughout your medical device’s design lifecycle​

Threat Modeling

The FDA pre-market guidance recommends threat modeling for all medical devices during the design stage and post-market lifecycle. ​

Our expert team will lead the threat modeling for your business and provide you with invaluable skills to autonomize the process.​

Penetration Testing​

The FDA pre-market guidance mandates pen testing, for all medical devices.​

Our team will help your business address medical device vulnerabilities, assess risks and ensure an appropriate level of independence between the two parties.​

Advisory Services​

The FDA and MDR Annex-I require a secure product development framework and alignment with AAMI-TIR-57.​

We provide security focused architecture reviews and security risk assessments during your medical device’s design phase. ​

Take this simple pre-assessment to get started.​

Startup Services​

Stay on top of pre- and post-market regulatory compliance across the medical device life cycle. ​

Ensure your business receives the best cybersecurity tools and guidance available. Join our startup program to fast-track your medical device cybersecurity.

Keeping you compliant with medical device regulations

Medical device cybersecurity regulations infographics: MDCG, NIS2, HIPAA, ADPPA, PATCH act

Join our connected healthcare partners:​

Frequently asked questions

What are the medical device requirements that I should know of?

There are several pre- and post-market requirements applicable for both the EU and the US markets. These include Security Risk Management, IMDRF MD Cybersecurity, Secure Product Lifecycle, SBOM Generation and SBOM Management.

Each market is also governed by its own set of regulations:

  • The EU market: GDPR, NIS2, Cybersecurity Act and the MDCG 2019-16
  • The US market: HIPAA + ADPPA, Patch Act, NIST Cybersecurity Framework, etc.

You can find the complete list of rules and regulations for both markets in our infographic.

How can threat modelling help my medical device security management?

Threat modeling helps identify potential threats that require mitigation and is an important step for market approval. It can help you make strategic decisions about the safety of your device and should be conducted throughout the device lifecycle, from conception through development and into commercialization.

What is penetration testing?

Penetration (pen) testing is the practice of conducting a product readiness assessment to help determine whether your medical device is ready for the market. The assessment highlights the approaches that real-world attackers might take when targeting your medical devices or software.

Can I get services if my business is only starting up?

MedTech cybersecurity protection should be easily scalable and accessible for all business sizes, startups included. In cooperation with our partners, we have a special program to help your medical devices from the get-go, irrespective of the of your business size. Contact us to make sure your business receives the best cybersecurity tools and guidance available.

What benefit do I have from advisory services?

We provide security-focused architecture reviews and security risk assessments during your medical device’s design phase. Contact us to learn more about how we can assist you with medical device cybersecurity.

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