“Thoughtful planning is the key here. It’s really hard to bolt on security at the end–it needs to be integrated up front, when you’re in your design input phase or even earlier during feasibility. That’s exactly what we help you do—build security into your foundation from the beginning.” –Melissa Masters, President
CMD MedTech helps companies navigate the complex world of medical device cybersecurity requirements. In this overwhelming space with over 50 consensus standards and dense FDA guidance documents and expectations, our experienced team provides practical solutions that balance regulatory expectations with business realities.
Why Choose CMD MedTech for Cybersecurity
- We’ve been working in this space since before formal FDA guidance existed
- One of our team members is an author of the first technical information report (TIR 57) on medical device cybersecurity
- Experience with both pre-market submissions and post-market cybersecurity management
- Risk-based approach that focuses resources on what matters most for your specific device
- Partnership with technical security experts for specialized implementation and testing
PRICING FOR OUR MEDICAL DEVICE CYBERSECURITY SERVICES
We tailor our cybersecurity services based on your device risk level and specific integration requirements. Several factors influence the scope and complexity of cybersecurity measures needed, including your device’s risk classification, the level of integration with hospital networks or electronic health records (EHR) systems, and whether the device handles, stores, or accesses Personally Identifiable Information (PII), or Protected Health Information (PHI), or Controlled Unclassified Information (CUI).
Lower-risk devices with minimal connectivity and no sensitive data access may take a lighter approach, while highly integrated devices with access to patient data require robust cybersecurity architectures. Contact us to discuss your project’s specific requirements and receive a customized proposal that addresses your device’s risk profile and integration needs.
Benefits of Our Cybersecurity Expertise
Cybersecurity Services and Solutions
Additional Services We Offer
Standards Mapping
We help determine which cybersecurity standards actually apply to your device from the dozens that might be relevant.
Customer Security Questionnaires
We assist with hospital and healthcare system security requirements beyond FDA expectations.
Vulnerability Management
We develop processes for tracking and addressing new vulnerabilities as they emerge.
Security Documentation Updates
We keep your cybersecurity documentation current as standards and threats evolve.
Incident Response Planning
We prepare appropriate response protocols for potential security events.
FREQUENTLY ASKED QUESTIONS ABOUT FDA CYBERSECURITY REQUIREMENTS FOR MEDICAL DEVICES
Cybersecurity needs to be considered from the beginning of development. In the feasibility and architecture stages, you should already be thinking about security implications. Waiting until later stages makes implementation much more difficult and potentially requires hardware changes that could significantly delay your project. However, we can help you no matter what phase you’re in, from early planning to remediation of existing devices.
Knowing which medical device security standards are applicable is overwhelming for most companies. There are over 50 consensus standards just for cybersecurity listed by the FDA. We help determine which standards are truly applicable to your specific device and implementation, saving you from unnecessarily applying requirements that don’t fit your situation.
FDA expects comprehensive cybersecurity documentation, including a threat model, risk assessment, software bill of materials (SBOM), architecture views, and detailed cybersecurity requirements implementation. The specific depth depends on your device risk level, but these elements need to be addressed in your submission. We can help you compile comprehensive cybersecurity documentation for FDA to meet regulatory requirements.
This can be challenging in healthcare settings. While security vulnerabilities are discovered frequently, medical devices can’t practically be updated constantly. We help develop reasonable post-market cybersecurity management plans that balance security needs with operational realities, meeting FDA expectations while being practical for your customers.
Yes, though it’s always easier to implement security from the beginning. For devices in development, we can assess your current approach and help implement necessary improvements. For marketed devices, we can help develop remediation plans that address security gaps while minimizing market disruption.