FDA Submissions &Audit Representation
Direct representation during FDA pre-submission meetings, deficiency responses, and on-site inspections. Our regulatory engineers prepare your documentation and stand alongside you through every interaction.
Engagement Types
Q-Sub & Pre-Sub Meetings
Preparation and representation for FDA Q-Submission and Pre-Submission meetings. We draft your cybersecurity questions, prepare supporting materials, and attend alongside your team.
Additional Information Responses
Expert authoring of AI responses to FDA cybersecurity deficiencies. We analyze the deficiency letter, identify root causes, and draft a complete, evidence-backed response package.
FDA Inspection Support
On-site or remote support during FDA facility inspections. Our team prepares your cybersecurity documentation, trains your staff on inspector interactions, and provides real-time guidance.
FSCA & Recall Coordination
Regulatory support for field safety corrective actions and voluntary recalls related to cybersecurity vulnerabilities. We manage FDA communications and documentation throughout.
Why MShield for Representation
Former FDA reviewers on staff
Our team includes engineers who have reviewed cybersecurity submissions from inside CDRH — we know exactly what reviewers look for.
End-to-end documentation ownership
We don't just advise — we author, review, and submit your complete cybersecurity documentation package.
Device-class expertise
Deep experience across Class II and Class III devices, SaMD, implantables, and IoMT — including high-risk combination products.
Engage Our Regulatory Team
Tell us about your submission or audit situation and we'll respond within one business day.
Facing an Upcoming FDA Deadline?
Our team can mobilize quickly. Contact us today to discuss your timeline and engagement options.