中文ENRU
Back to home
R&D documentation compliance · FDA eCopy

Make FDA 510(k) eCopy compliance checks 80% more efficient

Built on large language models and ontology-enhanced retrieval: a six-step closed loop from document import to report export, covering FDA eCopy technical compliance and professional writing standards.

See the servicesBook a demo
80%Faster compliance checking
6 stepsClosed-loop workflow
100+DHF documents delivered (PVMED)

Three capabilities, one service

Previously separate offerings — FDA/CE compliance, clinical evaluation, and DHF archiving — are now one end-to-end service.

1. FDA / CE compliance

Format and content compliance for FDA 510(k) eCopy submissions, plus CE usability assessment and internal audit requirements.

2. Clinical evaluation

Clinical evaluation and validation documentation meeting strict regulatory audit requirements.

3. DHF archiving

Design History File authoring and archiving covering software, cybersecurity, risk management and algorithm documentation.

A six-step closed-loop workflow

From document import to report export, with AI assistance at every step.

Document importImport the eCopy document set to be submitted
Format validationCheck PDF specifications and structural integrity
Content complianceCompare against FDA eCopy technical requirements
Writing standardsProfessional writing and terminology consistency check
Issue listOutput located issues and suggested fixes
Report exportGenerate a compliance report that can be archived directly

PVMED case: 100+ DHF documents in two months

PVMED is a medical software company that needed a complete Design History File (DHF) system to regulatory standards.

Scope and results

  • 100+ core DHF documents delivered within two months
  • Covering software, cybersecurity, risk management and algorithm documentation
  • Meeting strict internal audit data requirements
  • Consistent structure and terminology for later audits and iteration
Assess the ROI See the FDA workbench in detail

Accelerate your FDA compliance journey

Bring one of your real documents and see the six-step loop in action.

Book a free demo