Service

1. Overview of Manufacturing and Testing Environment and Relevant Equipment

Clean 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 Medical Device Innovation and Development Technology Service Platform and partners can provide system solutions for clean rooms.

2. Service Contents

Production solutions of sterile medical devices

Production solutions of implantable medical devices

Production solutions of IVD reagents

Clean environment verification solutions

Conventional equipment verification solutions

Special process verification solutions

3. Reference Standards

1. GB 50073 Code for design of clean room;

2. GB 50591 Code for construction and acceptance of cleanroom;

3. Good Manufacturing Practice Annex on Sterile Medical Devices (No.101 Announcement in 2015);

4. Good Manufacturing Practice Annex on Implantable Medical Devices (No.102 Announcement in 2015);

5. Good Manufacturing Practice Annex on IVD Reagents (No.103 Announcement in 2015);