Regulators are holding MDMs accountable to build secure-by-design medical devices
and keep them secure without reliance on user-level security controls within healthcare facilities.
With over five billion devices protected, our MedTech experts will help you design, build and ship secure, fully compliant products. Our commitment to quality is evidenced by ISO 27001 certification.
Medical Device Cybersecurity Advisory and Testing Services
Looking to outsource your cybersecurity-related activities, or strengthen your internal capabilities?
We can assist with:
- Gap assessments to manage regulatory deficiencies and non-conformities
- Assistance in building strong cybersecurity processes and documentation following IMDRF/CYBER WG/N60, MDCG 2019-16 and FDA pre- and post-market guidance
- Pen Testing and Threat Modeling in compliance with ANSI/AAMI SW96:2023
- Reviews and technical advice on your software architectures
Software and AI Protection Throughout Your Medical Device Life Cycle
Concerned about the safety of your intellectual property or adversarial attacks?
Get support to harden and protect both your medical device and software:
- Secure AI/ML for healthcare applications
- Prevent cloning/tampering of your models
- Protect your code at the binary level
- Guard medical devices against unauthorized access
Code Signing, Device Identity and PKI for Your Medical Device
Are you navigating the complexity of PKI?
Our cybersecurity solutions take the manual effort out and can assist you with:
- Design choices for code signing and device identity
- Ongoing management of keys, identities and secrets through a fully managed service approach
- Build on-premises PKI management
- Critical support offerings:
- Guidance on code signing and device identity design
- Consultation for optimizing your PKI infrastructure
- Comprehensive management of keys and identities
- Fully managed service approach for secret managemen