AI Regulatory Submission Writer
Regulatory submissions to the FDA, EU Notified Bodies, and other authorities require precise formatting, exhaustive evidence, and airtight traceability. Vespper helps you draft submissions faster while maintaining the rigor regulators expect.
1. EU MDR Technical Documentation
EU MDR Annex II and III define the technical documentation requirements that must accompany every CE-marked medical device.
Annex I — General Safety and Performance Requirements (GSPR)
- GSPR checklist mapping each requirement to supporting evidence documents
- Justification for non-applicable requirements with documented rationale
- Cross-references to risk management file, clinical evaluation, and testing reports
Annex II/III — Technical Documentation Structure
- Device description and specification including variants and accessories
- Design and manufacturing information with process validation evidence
- EU Declaration of Conformity with harmonized standard references
- Summary of Safety and Clinical Performance (SSCP) for implantable and Class III devices
- Incomplete GSPR mapping is the most common reason for Notified Body technical documentation audit findings
- SSCP must be prepared for EUDAMED publication — Notified Bodies verify accuracy against full technical documentation
2. FDA Submission Requirements
FDA submissions follow pathway-specific structures with distinct documentation requirements for each clearance or approval route.
510(k) Premarket Notification
- Substantial equivalence demonstration to legally marketed predicate device
- eSTAR (Electronic Submission Template and Resource) format compliance
- Performance testing data with statistical analysis appropriate to device type
De Novo Classification and PMA
- De Novo request with proposed classification and special controls
- PMA supplement requirements for design, manufacturing, or labeling changes
- eCopy formatting standards for electronic submission packaging
- FDA refuse-to-accept (RTA) decisions commonly cite missing substantial equivalence data or incorrect eSTAR formatting
- De Novo submissions require more extensive evidence than 510(k) — insufficient evidence is the primary rejection reason
3. International Regulatory Frameworks
Global market access requires submissions tailored to each regulatory authority's specific documentation format and requirements.
Health Canada & MDSAP
- Medical Device Regulations SOR/98-282 classification and licensing requirements
- MDSAP audit program covering 5 jurisdictions with single audit methodology
- Medical Device Single Audit Program documentation alignment across regulatory systems
Japan PMDA & China NMPA
- PMDA Shonin (approval) and Todokede (notification) pathway documentation
- NMPA registration dossier requirements including China-specific testing
- Local authorized representative documentation requirements per jurisdiction
- Each jurisdiction may require country-specific clinical data or testing — a single global dossier is rarely sufficient
- MDSAP findings in one jurisdiction can trigger audit consequences across all five participating countries
4. Quality Management Integration
Regulatory submissions must demonstrate alignment with the manufacturer's quality management system throughout the product lifecycle.
ISO 13485:2016
- Design History File (DHF) traceability from user needs through design verification and validation
- Risk management file per ISO 14971:2019 integrated with design controls
- Post-market surveillance system documentation and feedback mechanisms
- Submissions lacking QMS traceability raise Notified Body concerns about manufacturing consistency
- Risk management file must be cross-referenced throughout the submission — isolated risk documents are insufficient
What happens when documentation falls short
- Regulatory submission rejection requiring complete resubmission with 6-18 month delays
- FDA 510(k) refuse-to-accept decision from documentation deficiencies
- Notified Body audit findings requiring corrective action before CE marking
- Market access delays in multiple jurisdictions from inconsistent documentation
What this means for your team
How Vespper helps you write regulatory submissions
Multi-source document integration
Upload test reports, clinical data, design files, and risk assessments. Vespper synthesizes them into a structured submission with cross-references.
Authority-aligned structure
Generate submission documents following FDA, EU MDR, or other regulatory frameworks with proper section organization and numbering.
Claim-to-evidence traceability
Every statement in your submission links to the specific test report, study, or design document that supports it.
Collaborative review workflow
Share drafts with cross-functional teams, review AI suggestions in diff view, and maintain a complete revision history for regulatory records.
Draft your regulatory submission in 3 steps
Upload supporting documentation
Connect test reports, clinical data, risk analyses, design documentation, and predicate device comparisons.
Generate submission draft
Vespper drafts your submission following the target authority's structure, with claims traced to uploaded evidence.
Review and submit
Review every section, verify cross-references, refine AI-generated content, and export in the required format.
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