AI Document Editor for Regulatory Affairs Teams
Regulatory affairs teams produce the most consequential documents in their organization — submissions that determine market access, technical files that survive auditor scrutiny, and compliance records that prove adherence. Vespper is built for this kind of writing.
1. EU MDR Compliance Landscape
Regulatory affairs teams must navigate the full scope of EU MDR requirements across the product lifecycle.
EU MDR 2017/745
- Classification rules (Annex VIII) determining documentation tier requirements
- Annex I General Safety and Performance Requirements mapping
- Annex II technical documentation requirements and Annex III post-market surveillance documentation
- EUDAMED registration and UDI-DI assignment obligations
- Higher-risk classification triggers more extensive documentation requirements that RA teams must manage
- EUDAMED submission deadlines require coordinated documentation readiness across multiple deliverables
2. FDA Regulatory Pathways
US market access requires pathway-specific documentation that RA teams must prepare and maintain.
FDA Submission and QSR
- 510(k) premarket notification process and substantial equivalence demonstration
- De Novo classification and PMA requirements for novel devices
- Quality System Regulation (21 CFR Part 820) documentation requirements
- Unique Device Identification (UDI) system requirements and GUDID registration
- Each FDA pathway has distinct documentation requirements that cannot be interchanged
- QSR documentation must be maintained continuously — not just prepared at submission time
3. International Market Access
Global regulatory strategies require documentation tailored to each market's requirements.
Multi-Jurisdiction Requirements
- Health Canada Medical Device Regulations and licensing requirements
- MDSAP audit program covering 5 jurisdictions with single audit approach
- Japan PMDA Shonin and Todokede pathways with Japan-specific clinical requirements
- Australia TGA registration and conformity assessment procedures
- MDSAP findings affect all participating jurisdictions simultaneously
- Each market may require country-specific clinical data beyond global dossier content
4. Quality & Post-Market Systems
RA teams interact with QMS documentation throughout the product lifecycle for submissions and maintenance.
ISO 13485 and Post-Market Surveillance
- QMS documentation requirements interfacing with regulatory submissions
- Post-market surveillance per EU MDR Articles 83-86
- Vigilance reporting per Articles 87-92 with timeline requirements
- Field safety corrective actions and recall documentation
- Post-market surveillance reports feed into regulatory submissions and must be kept current
- Vigilance reporting timelines are strict — serious incidents require reporting within 15 days
5. Documentation Standards & Traceability
RA teams must ensure all documentation meets applicable standards for structure, labeling, and traceability.
Labeling and Instructions
- IEC/IEEE 82079-1 for user instruction documentation
- EU MDR Annex I Chapter III labeling requirements
- Electronic instructions for use (eIFU) per EU 2021/2226
- Translation and localization requirements per market
- Labeling non-compliance is a high-frequency Notified Body finding that can delay certification
- eIFU regulations have specific conditions that must be met to replace paper IFU
What happens when documentation falls short
- CE marking delays from incomplete technical documentation
- FDA warning letters from QSR non-compliance
- MDSAP audit findings affecting multiple market authorizations simultaneously
- Product recalls from inconsistent documentation across markets
- Missed compliance deadlines from regulatory intelligence gaps
What this means for your team
How Vespper serves regulatory affairs teams
Native source traceability
Every claim in your regulatory document links to the test report, clinical study, or design document that supports it — no separate traceability matrix needed.
Authority-specific templates
Draft documents following FDA, EU MDR, Health Canada, or other authority-specific structures with proper section organization.
Auditable revision history
Every edit is tracked with full before/after visibility, who made the change, and when — meeting regulated environment requirements.
Cross-document consistency
Maintain consistent terminology, product descriptions, and claims across your entire regulatory document portfolio.
How regulatory teams use Vespper
Connect your regulatory data
Upload test reports, clinical data, design documentation, predicate comparisons, and regulatory guidance documents.
Draft regulatory documents with AI
Generate submissions, CERs, technical files, or risk assessments with every claim traced to your source evidence.
Review, revise, and submit
Review AI suggestions in diff view, maintain auditable revision records, and export in authority-required formats.
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The document editor regulatory affairs teams deserve
Draft regulatory documents with built-in traceability, structured output, and auditable revisions.
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