1. Medical Device QMS/GMP Facility

Brief Introduction

1. Our complete QMS/GMP compliant facility is built upon the foundation of extensive design and development documentation and experience, allowing us to utilize high-quality technology for medical device trial production and mass manufacturing.

2. We establish testing services and pilot production lines to assist with new technology validation and bridge the last mile to commercialization.

3. Driving the small-batch prototyping of innovative services and products, and supporting the incubation of new ventures.

4. The iKNOBeads product, the micro-chemical analyzer for clinical use, and the novel coronavirus nucleic acid test reagent have all received QMS clearance/registration (2023).

5. iPMx analyzer and COVID-19 reagent kit received TFDA Special Project Manufacturing Approval and was submitted for regulatory registration in Japan (2020).

6. GMP factory and manufacturer licenses obtained (2019).

7. ISO 13485 certification acquired (2019).

Scope of Services

QMS/GMP consulting for electrical medical devices and reagent-based IVDs (including facility planning, plant build-out, quality documentation, and process development).

Core Facilities

1. Four main areas: medical-electronics assembly plant, reagent filling/aliquoting plant, warehouse, and quality-control laboratory.

2. Key equipments: isolator workstation, biosafety cabinet, HPLC system, flow cytometer, particle counter/particle-size analyzer, spectrophotometer, automated cell counter, analytical balance, refrigerated/freezer units, oscilloscope, and power supplies.

Info

• 陳筑瑄 專案經理

• +886-3-5919138

• EmilyChen@itri.org.tw