FDA Cybersecurity Deficiency Response Services
We provide assistance to manufacturers on FDA deficiency letters as regards technical remediation, updated documentation, and help in resubmitting.
Qualysec supports medical device manufacturers with cyber security testing, threat modelling, risk assessment, and security documentation support for submission to the FDA's 510(k) requirements.
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Our Services
Qualysec provides medical device manufacturers with cybersecurity testing and threat modeling, FDA documentation, and deficiency response support throughout the FDA submission lifecycle, from premarket planning to postmarket monitoring.
We provide assistance to manufacturers on FDA deficiency letters as regards technical remediation, updated documentation, and help in resubmitting.
We assist with the cybersecurity activities necessary for submission, such as documentation, risk assessment, testing, as directed by FDA guidance and Section 524B.
We identify and address software vulnerabilities in Software as a Medical Device through architecture reviews and penetration testing.
We conduct vulnerability testing, penetration testing, SBOM validation and protocol testing to secure connected medical devices before submission.
We help manufacturers maintain compliance after product launch through continuous monitoring, vulnerability management, and coordinated disclosure support.
We create FDA ready cyber security documentation such as SBOM, threat modeling, risk management documentation and architecture documentation to be submitted.
FDA Requirement
Every FDA 510(k) submission for a connected medical device requires these 14 cybersecurity documents as supporting evidence.
Our structured testing approach takes your medical device from initial risk assessment to FDA submission to postmarket monitoring.
We discuss your device, purpose and cyber security definition.
We identify threats and assess impact on device safety.
We conduct penetration testing, protocol testing, and SBOM validation.
We prepare all 14 required documents with technical evidence.
We patch vulnerabilities and test security controls before submitting.
We prepare your submission package and support the FDA review.
We monitor vulnerabilities and maintain compliance after product launch.
Testimonials
Read what our clients say about our services. See how Qualysec has helped several businesses to keep their digital assets safe!
Qualysec did a great job identifying vulnerabilities in our web and cloud applications and gave us clear steps to fix them. They stuck to deadlines, handled re-tests, and supported well.
Product Manager
Get a Quote
Book a free initial consultation to discuss your medical device's specific needs and how our FDA 510(k) compliance penetration testing can help secure FDA approval. We share a personalized quote based on your device's complexity and testing needs.
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FAQ
Get quick answers to common questions about FDA 510(k) clearance, cybersecurity testing, documentation, and Qualysec support.