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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

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