Create Your Own Custom Milestones!
Sample Milestones for Regulatory Submissions
Dynamic Milestone Manager will transform the way medical device and pharmaceutical companies track, manage, and optimize regulatory submissions. With its intuitive, flexible framework, Dynamic Milestone Manager ensures every critical regulatory deadline, document, and approval is organized, captured, tracked, and managed with precision. From initial submission preparation to final approval, our solution allows teams to stay aligned to document and ensure compliance at every step. Empower your regulatory affairs leaders with tailored milestone tracking, and real-time status updates—helping your teams reduce delays, improve collaboration, and streamline the complex regulatory submission process, all while maintaining full compliance and visibility across departments.
Sample Regulatory Milestones
FDA Regulatory New Submission – USA
Milestone: Pre-Submission & Regulatory Strategy Development
Key Fields:
Device Classification (Class I, II, III)
Regulatory Pathway Identified (510(k), PMA, De Novo, etc.)
Pre-Submission Meeting Scheduled?
Risk Assessment Completed?
Intended Use & Indications Defined?
Milestone: Preclinical Testing & Data Collection
Key Fields:
Bench Testing Completed?
Biocompatibility Testing Completed?
Animal Studies Conducted?
GLP Compliance Verified?
Data Ready for Submission?
Milestone: Clinical Study & Evidence Gathering
Key Fields:
Clinical Trial Required?
Investigational Device Exemption (IDE) Approved?
Sites & Principal Investigators Identified?
Patient Enrollment Progress
Study Completion Date
Milestone: Submission Preparation & Filing
Key Fields:
Regulatory Submission Type (510(k), PMA, etc.)
Application Completed?
All Required Documents Included?
Submission Date
FDA Review Clock Start Date
Milestone: FDA Review & Interactions
Key Fields:
Review Status (Acceptance, Refuse to Accept, Additional Info Required)
FDA Requests for Additional Information?
Responses Submitted?
Advisory Panel Required?
Final Decision Date
Milestone: Market Clearance & Post-Market Obligations
Key Fields:
510(k) Clearance or PMA Approval Date
Labeling & Packaging Approved?
Post-Market Surveillance Plan Ready?
Adverse Event Reporting System in Place?
Compliance Audit Scheduled?
CE Marking & Regulatory Approval – France
Milestone: Regulatory Planning & Gap Analysis
Key Fields:
Device Classification (Class I, IIa, IIb, III)
Intended Use & Risk Category Defined?
Regulatory Pathway (Self-Certification vs. Notified Body) Identified?
Clinical Data Requirements Assessed?
Economic Operators (Manufacturer, Importer, Distributor) Assigned?
Milestone: Technical Documentation & Risk Management
Key Fields:
General Safety & Performance Requirements (GSPR) Addressed?
Risk Management File Completed?
Usability & Performance Testing Conducted?
Clinical Evaluation Plan Approved?
Post-Market Surveillance Plan Developed?
Milestone: Clinical Evaluation & Testing
Key Fields:
Clinical Study Required?
Clinical Investigation Application Submitted?
Notified Body Consultation Completed?
Clinical Evaluation Report (CER) Finalized?
Post-Market Clinical Follow-up (PMCF) Plan Approved?
Milestone: Submission to Notified Body & Review
Key Fields:
Notified Body Selected?
Conformity Assessment Route Confirmed?
Quality System (ISO 13485) Certified?
Submission Date
Notified Body Questions Addressed?
Milestone: CE Marking Approval & Declaration of Conformity
Key Fields:
CE Certificate Issued?
Declaration of Conformity Signed?
Device Added to EUDAMED?
Labeling & UDI Compliance Confirmed?
EU Market Launch Date?
Milestone: Post-Market Surveillance & Regulatory Compliance
Key Fields:
Post-Market Surveillance Plan Activated?
Incident Reporting System Established?
Periodic Safety Update Report (PSUR) Completed?
Audit & Compliance Checks Scheduled?
MDR/IVDR Updates Monitored?