醫療器材法規顧問公司
暫不提供
10人
台北市內湖區台北市內湖區成功路四段188號9樓之25
• Headquarted in Hong Kong, Vee Care Asia is a ISO 13485 accredited medical device regulatory consultant company. 威康有限公司 is its subsidiary in Taiwan and is now holding more than 50 foreign companies in Taiwan. • Vee Care is an ISO 13485 certified medical device regulatory consultant company providing a full range of design and compliance services to global medical manufacturers. • Founded in 2013 with sole focuses on US 510k and EU MDR regulation services, it has now grown into a one-stop shop solution provider offering design support services, quality systems set-up, technical documentation as well as product registration to key global markets. • Company Website: https://vee-med.com/
The Company is now providing the following regulatory services to medical manufacturers. - Technical Documentation for CE / 510k - Quality System Set-up (ISO 13485 / FDA QSR/MDSAP) - License Hosting (EU/US/Taiwan/ASEAN) - Product Validation Services - Biocompatibility Tests (ISO 10993 Series) - Electrical Safety Test (IEC/AMI 60601 Series)