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.

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80%Faster compliance checking

6 步Closed-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.

文档导入导入待提交的 eCopy 文档集

格式校验检查 PDF 规范与结构完整性

内容合规比对 FDA eCopy 技术要求

写作规范专业写作与术语一致性检查

问题清单输出可定位的问题与修改建议

报告导出生成合规检查报告，可直接归档

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.

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