Regulatory Submissions
Plan, prepare, and track regulatory submissions across global markets including 510(k), PMA, EU MDR, and other submission types. Manage the entire submission lifecycle from planning through authority review and approval with complete documentation.
Key Capabilities
What you get with the Regulatory Submissions module.
How It Connects
Regulatory Submissionsdoesn't work in isolation. It connects seamlessly with other modules in MoniDoseQMS for full traceability across your quality system.
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Book a 30-minute demo tailored to your regulatory needs. Our team will walk you through how Regulatory Submissions works within your specific compliance context.
More in Regulatory Affairs
Explore other modules in the Regulatory Affairs category.
Product Registrations
Track and manage product registrations across multiple global markets with status monitoring and renewal tracking. Maintain a centralized registry of all regulatory approvals, clearances, and registrations to ensure your market access is always current.
UDI Records
Manage Unique Device Identification records and ensure compliance with FDA UDI Rule, EU MDR UDI requirements, and other global UDI mandates. Maintain accurate device identifier data and keep your UDI database submissions current across all required markets.
GUDID Submissions
Prepare and track submissions to the FDA Global Unique Device Identification Database. Ensure your device listing information is accurate, complete, and submitted on time to maintain compliance with FDA UDI requirements.
Declarations of Conformity
Create, manage, and maintain EU Declarations of Conformity as required by EU MDR Article 19. Ensure your DoC documents are complete, accurate, and updated whenever changes affect conformity, with templates that cover all required elements.
CE Marking Procedures
Document and manage your CE marking conformity assessment procedures aligned with EU MDR Annex IX-XI. Track conformity assessment routes, notified body interactions, and ensure all prerequisites are met before applying the CE mark to your devices.
Essential Requirements
Demonstrate compliance with EU MDR Annex I General Safety and Performance Requirements through structured checklists and evidence mapping. Maintain a living GSPR checklist that links each requirement to supporting evidence in your technical documentation.