Yigui AI — Your Full-Chain Medical Device Compliance AI Assistant, Now Officially Live!

Still struggling with product registration strategy reports and NMPA registration pathways? Still searching through endless job postings like looking for a needle in a haystack? Hlongmed’s Yigui AI is here to solve your compliance challenges in the medical device industry!

Backed by 16 years of research and consulting experience in the medical device industry—from NMPA to FDA to CE—Yigui AI covers the entire chain of AI‑assisted services, from product strategy, design & development, regulatory registration, and clinical trials, to post‑market surveillance and career development.

Four core features, one integrated solution:

Product Registration Strategy Report: Upload your product instruction manual; AI automatically extracts product information. Select your target countries/regions (supporting NMPA, FDA, CE, Japan PMDA, Korea MFDS, Health Canada, Brazil ANVISA, and more). The system intelligently generates a comprehensive registration analysis report including classification determination, registration workflow, applicable standards, cost estimation, and direct links to regulatory source texts. Works for both medical devices and in vitro diagnostic (IVD) products—all with one click.

NMPA Registration Pathway Planning: AI-driven full-path planning based on your product manual, covering a 7‑framework analysis:

Product information extraction & structuring → Classification determination (based on the Medical Device Classification Catalog and IMDRF risk framework) → Pathway selection (Normal / Innovative / Import, with three route types) → Work breakdown & timeline planning → Risk identification (five dimensions: classification, clinical, cybersecurity, QMS, software updates) → Documentation checklist generation → Regulatory reference guidance.

Smart Job Matching: Upload your resume, and the AI automatically searches and matches positions from major job boards, generating a full‑dimensional analysis report: search overview, top position rankings, common traits of high‑match positions, gap analysis, tiered recommendations, target company insights, and career development pathways—making your job search more precise and efficient.

Yigui AI Assistant: Proficient in regulatory compliance, quality systems, design & development, risk management, and more. Ask any question at any time and get instant answers. For example: What documents are required for NMPA registration? How to conduct ISO 14971 risk management? What does the DHF (Design History File) include? What is the 510(k) submission process? – instant answers at your fingertips.

Visit our website now at mdcpp.com to sign up for a free membership and receive 50 Yigui Coins to experience the full suite of compliance AI features!

Try it now: https://www.mdcpp.com/