Our specialties lie in innovative products registration, MAH（Marketing Authorization Holder） in medical device industry, providing agent service for overseas MD（medical device） manufacturers who intend to register their products in China, calling an expert seminar quickly and GCP/GSP/GMP/GLP review as well.

Beijing RunHuge STD., provide one package solution of medical devices registered in China for more than 20 years including technical standards, product testing, clinical evaluation, R&D planning, quality system, is dedicated to the delivery of registration services for global manufacturers. We have accumulated plentiful experience in registration industry and fully used our high-quality resources to serve more than 3,000 enterprises covering over 98% of the products in classification catalogue. Our services include proposal planning, category classification, report compilation, testing & verification, prototype correction, registration declaration.

Our clinical trials center, has more than 20 years’ experience in proceeding clinical trials of drugs and medical devices, is led and established by masters and doctors of medicine from PLA general hospital（A.K.A 301 hospital in China）, predecessor of Air Force General Hospital. This center is committed to do clinical trials and validation for MDs. We also provide hospital selection, meeting preparation of the EC and post-discussion, proposal design and whole process follow-up during clinical trials, corresponding statistics analysis and CER（Clinical Evaluation Report） making.

We provide Design & Development services, including R&D planning, proposal argumentation, process guidance, verification & correction & conversion of design.

We interpret the newly-enacted laws and share the latest industrial information through organizing communication and training of medical devices in order to establish a communication bridge among the global manufacturing enterprises.

(1) Preliminary stage: investigation and diagnosis, assisting enterprises in rational adjustment and utilization of resources.
  1. On-site visit, talk with business leaders and quality management personnel to understand the current situation of the company;
  2. According to ISO13485, formulate practical and feasible rectification plans based on the current situation of the enterprise;
  3. Assist enterprises to establish or optimize the quality management organization structure;
  4. Assist the company to establish an internal certification team;
(II) Implementation stage: Initial training:
1. Tell the basic knowledge of the quality system and the significance of the enterprise implementation quality system.
2. Assist the enterprise in hardware transformation: Provide the company with standardized and feasible hardware transformation opinions; 3. Supervise and inspect the transformation process and evaluate the transformation effect;
4. The establishment and implementation o