Wellkang Tech Consulting
| About us | Wellkang Group is a world leading consultancy group specialized in global regulatory affairs such as: US FDA compliance including Food registration, Medical device 510(k) PMN submission; UL mark; China Compulsory Certification- CCC Mark; European Union&EFTA product safety requirement- CE Marking; European regulations on cosmetic products, etc. Wellkang help worldwide exporters to gain global market access. Wellkang have offices in Asia, Europe and America. A world leading consultancy offers you excellent services at very competitive prices! How can Wellkang help you? Wellkang's mission is to provide a comprehensive range of business services aimed at assuring the European product conformity. The in-depth expertise of our professionals and an extensive working experience in a wide industrial spectrum enable us to achieve this goal. Wellkang strives to establish a close, trusting relationship with our clients based on proven performance and total dedication to their products. 1. EU Documentation and Standards Delivery Service. * 1.1 EU Product Directives * 1.2 European Standards * 1.3 Other EU Official Documents 2. Technical Consulting Service * 2.1 Technical Advice on Compliance Engineering * 2.2 Safety and Risk Assessments 3. Compliance Testing Service * 3.1 Pre-compliance testing arrangement * 3.2 Full-compliance testing arrangement 4. Technical Documentation Service * 4.1 Technical Files(TechnicalDocumentation): Guiding you preparing this document. * 4.2 EC Declaration of Conformity: Guiding you preparing this document, we have different models in several languages. 5. Labeling and Document Translation Can arrange the translation from English into the official language(s) of every EU member state) * 5.1 Users Manual and Installation Instructions * 5.2 Labeling Advice and Translation 6. EU Authorized Representative Service * 6.1 Product Registration: We can register your product in EU for the first time and get your product a Certificate of Registration. * 6.2 Renewal and Update Product Registration: The product Certificate of Registration is valid for one year only and must be renewed annually. The information about the product must be updated whenever it changes and at least once a year when renew the product Certificate of Registration. * 6.3 Keep Your Technical Files: We store and update the Technical Files of your products sold in Europe, and makes them available timely to the appropriate surveillance/vigilance authorities upon request. * 6.4 Legislation Monitoring: We monitor and report on new developments in European product legislation relevant to your products. * 6.5 Vigilance and Incident Reporting: We assist with product vigilance and incident reporting. * 6.6 Product Recalls and Advisory Notices: We assist with Product Recalls and the issuing of Advisory Notices |
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| Industry Focus | Trading Consulting, Medical Equipment, Medical Testing & Laboratory Apparatus, Cosmetics |
| Business Type | Agent |
| Products/Services | We help non-EU exporters obtain CE Marking. Offer consulting&EU Authorized Representative service for Medical Devices, Personal Protective Equip, Electrical Equip, Machinery, Toys, Cosmetic etc. |
| Our Markets | Western Europe |
| No. of Employees | 5 - 10 People |
