Getting to know more about us here ..........

We are an ISO9001/ISO13485 compliant, CE/MDD certified and U.S. FDA validated manufacturer operate out of Hong Kong with manufacturing facility in China; pursue the design & manufacturing (ODM) and private labeling (OEM) a wide variety of electrical/electronic devices and gadgets with different polymeric materials for the personal and healthcare markets. Founded in 1994, Well Brain International [WBI] is a multinational company with direct presence in Asia, Canada, Europe and the United States, provides unique solutions for those of the personal and healthcare products industry who are committed in the delivery of value added products to consumers and plan to strategically remain leading on the highly responsive market.

We also provide to medical device manufacturers* with multiple services for meeting the Health Canada and the U.S. FDA regulatory requirements for medical devices to be sold in Canada and the United States, specific consulting services include (i) Establishment Registration; (ii) Official Correspondence and U.S. Agent Services; (iii) Medical Device Initial Importer Services; (iv) Medical Device Listing; (v) Medical Device Labeling; (vi) Documentation and Submission of 510k Application for Device Approvals and Clearances; (vii) Clinical Trials and Laboratory Tests for Standards Compliance; (viii) ISO14971 Medical Device Risk Management, and more.........

Well Brain International [WBI] is your source of innovative products, a valued partner for capitalizing on the emerging market the growth opportunities.  Contact us whenever you are ready to discuss your next project!

*Medical Device Manufacturers are herein being referred the legal entities who assign/contract/subcontract the manufacturing of medical devices in China for exporting to Canada and the United States.

 

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