Due to the stringent requirements for safety and efficacy of medical device products, medical device manufacturers in Taiwan are required to undergo Good Manufacturing Practice (GMP) audit before applying for product registration.
In addition, medical device made in Taiwan need to comply with local regulations before exported to different countries. ISO known as the most credibility certification organization, obtaining ISO 13485 medical device quality management system certification is an important strategy for medical device manufacturers toin exporting products.
License Biomedical Co., LTD is qualified as the auditors of ISO 13485 and ISO 14001. Our team can lead you to become familiar with the requirements and assist you in setting up a quality management system and the preparation of ISO 13485 and GMP.
In addition, medical device made in Taiwan need to comply with local regulations before exported to different countries. ISO known as the most credibility certification organization, obtaining ISO 13485 medical device quality management system certification is an important strategy for medical device manufacturers to
License Biomedical Co., LTD is qualified as the auditors of ISO 13485 and ISO 14001. Our team can lead you to become familiar with the requirements and assist you in setting up a quality management system and the preparation of ISO 13485 and GMP.
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