1.This QMS/GMP facility enables the production of regulatory-compliant biomedical material products for clinical trials, accelerating market readiness and increasing industry collaboration willingness.
2.It supports domestic companies with pilot-scale production for clinical validation, reducing development costs and risks, while also serving as a training ground for teams specializing in implantable medical devices, enhancing Taiwan’s capability to develop high value-added products.
˙Established ASTM F2255, F2256, and F2258 tissue sealing process validation procedures.
˙Implemented ISO 13485:2016 quality management system and obtained factory registration and manufacturer’s license.
˙Complies with TFDA QMS/GMP, ISO 13485, EU CE 93/42/EEC, and U.S. FDA regulatory requirements.
˙Equipped with two preparation rooms and three processing rooms for R&D pilot production and device-related testing.
QMS/GMP Services
Small-scale pilot production of Class III implantable passive medical devices.
Clinical trial support for industry and medical centers.
Implementation and practice of ISO 13408 and ISO 14971 standards.
Assistance in device development and pilot production with ISO-compliant documentation.
Reduction of initial equipment investment and shared development cost.
Support for local SMEs developing import-substitute products.
Facilitation of product diversification for different end-user markets.
Customized Services
Regulatory consultation, facility design consultation, and quality validation services.
Support for pilot testing, method validation, and contract manufacturing.
1.ISO Class 7 (Class 10,000) cleanroom
2.Freeze dryer
3.Chemical fume hood
4.RABS (Restricted Access Barrier System)
林立傑
13594