What does it mean?
GEMORE Technology Co., Ltd. has received ISO 9001 and ISO 13485 certification. ISO 9000 is a series of international standards first published in 1987 by a technical committee of the International Organization for Standardization. They were developed to provide countries worldwide with a universal baseline for defining quality expectations, which would eliminate confusion and facilitate international trade. GEMORE currently holds EC-Certificate Number TW08/00472 which meets the requirements of Council Directive 93/42/EEC, Article 11.2.b and Certificate Number TW08/00470 and operates a quality management system which complies with the requirements of NS EN ISO 9001: 2000 and ISO 13485: 2003. The license scope includes design and manufacture of electro medical devices in accordance with NS-EN ISO 9001:2000 and ISO 13485:2003. Now all update to ISO13485:2016.
CE 1639 indicates that GEMORE products comply with the set requirements for safety, health, environment and consumer protection. The CE mark may only be placed on products which have been tested to safety standards and meet the requirements of the Medical Device Directive 93/42/EEC.