Service & Tech

Service & Tech
Environment, Equipment, and Special Processes

1. Overview of Manufacturing and Testing Environment and Relevant EquipmentClean rooms are essential for the production of sterile/implantable medical devices and IVD reagents. The control level of environment and equipment in them directly influences the quality of medical devices. Tigermed-Jyton M

Simulated Inspection

Simulated assessment: At the first registration stage of the medical device, we perform a simulated assessment for the factory before on-site assessment by the NMPA assessor. It is an in-process service to find out and fix any possible problem in advance. It is generally needed before product market

GMP/GSP System Counseling

1. OverviewIn accordance with Good Manufacturing Practice(GMP) and Good Supply Practice(GSP), the enterprise should establish and improve a Quality Management System which is applicable to the medical devices manufactured and operated and guarantee its effective operation based on releva

License Application

Production License OverviewIn accordance with Regulations on the Supervision and Administration of Medical Devices (No.650 Decree of the State Council of the People’s Republic of China), on the premise of conditions specified for medical device production, manufacturers of Class II and III medical

The Registrant System/MAH

1. Service OverviewIn accordance with the Notice on Extending Pilot Work of the Medical Device Registrant System(G.Y.J.X.Z.[2019] No.33) issued by the NMPA, we are dedicated to promote the pilot work of the medical device registrant system. Our services can solve practical difficulties faced b

 Statistical Analysis

Biostatistics service conrentsOffer comments to the Chinese Biostatistics Society as an authority, and participate in data standard setting, quality and biostatistics related projects of CFDACommunicate with the drug supervision administration in terms of statisticsClinical trial design and consulti