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Cybersecurity Compliance
How We Help and Why It Matters
- QCC develops FDA-ready cybersecurity documentation for 510(k) and PMA submissions and organizes each deliverable into a submission-ready structure aligned with agency expectations for FDA Cybersecurity Medical Devices.
- QCC brings experience applying FDA Postmarket Cybersecurity Guidance and prepares medical device cybersecurity plans tailored to company processes and postmarket obligations.
- When FDA issues an Additional Information request, QCC identifies documentation gaps that triggered the request and executes targeted action plans to deliver complete and defensible responses.
- QCC provides medical device cybersecurity testing support, including test planning, penetration testing, and related verification and validation activities.
- QCC advises documentation teams on cybersecurity labeling considerations that support clearance and compliance.
- For federally funded programs that require cybersecurity risk planning and reporting, QCC provides cybersecurity compliance and documentation support aligned with government expectations.
Trust QCC’s Expertise on FDA Cybersecurity Medical Device Guidance
QCC applies current FDA Premarket Cybersecurity Guidance, FDA Postmarket Cybersecurity Guidance, and other applicable U.S. and EU requirements to help device documentation align with FDA expectations. We meet teams where they are and keep regulatory filings lean while supporting risk reduction and efficient clearance timelines.
