Empowering certification throughout the entire cycle, safeguarding your business projects with resources
Scope of Services
The Four Major Core Medical Certifications
We are deeply rooted in four core medical fields, and our experience and resource platform have become a 'golden brand' in the industry.
1
Domestic Medical Device Filing and Registration
Professional handling of various equipment registration certificates and business licenses.
2
Clinical CRO Trial Platform Collaboration
Efficiently conduct clinical evaluations, trial design, and data management.
3
Medical Device CRDMO Industrial Park Planning
Building a professional park from scratch, providing one-stop industry services.
4
International Medical Device System Training Guide
In-depth analysis of system standards such as ISO 13485 and QSR820.
Our core competitiveness
Senior Expert Team
A team of experts with over 20 years of experience in medical device manufacturing, operations, and certification consulting, familiar with regulations and audit requirements in various countries.
Green Channel
With abundant industry resources, we can effectively shorten the registration and filing cycle for medical device, cosmetic, and health product approvals, speeding up the time to market.
Full lifecycle service
From the early stages of factory design and cleanroom design, to the mid-stage clinical trial CRO, and finally to the later stage of production license processing, we accompany you throughout the entire process.
Service Process
Standard Processes & Other Certifications
Step1
Initial Consultation
One-on-one requirement communication to establish a file
Step2
Solution Design
The expert team reviews and formulates a special plan
Step3
Resource matching
Accurately Match Resources for Efficient Application
Step4
Progress Follow-up
Application Effect Tracking and Ongoing Progress Management
International Certification (FDA/CE)
Assist domestic companies in entering the global market. This includes U.S. FDA 510(k) and PMA submissions, as well as EU CE MDR/IVDR certification and technical documentation preparation, and handling of export sales certifications.
We provide 'full lifecycle support' services, ranging from R&D transformation, compliant manufacturing, global registration to overseas marketing, supply chain finance, and IPO advisory, helping medical device companies achieve the leap 'from local to global'. 1. Research and Development and Production Services (CR-D) — Solving the problems of 'making it' 2. Market and Overseas Services (M-O) — Solving the 'Selling Out' Problem 3. Financial and Capital Services (F) — Addressing the Issue of 'Cash Flow'