Fameux Medical specializes in consulting for CE Certification of Medical Devices. For companies requiring a CE mark for their product for exporting to the European Community, the Company assists with interpreting the standard and outlining the requirements for obtaining the CE mark. The company gives complete guidance and advice from site / plant compliance to documentation e.g. Device Master File preparation, implementation of system as per MDD/93/42 and training to staff of Medical Device manufacturers to obtain CE marking for their medical devices. The company's completed and ongoing assignments for CE certification include Devices falling in class A, B, C & D
As part of the CE requirements a Device Technical File has to be prepared to outline the safety requirements of the product and risk management. Fameux medical will assist you in the preparation of the Technical File to meet the review of the third party certification.
The CE Mark Certification requires a third party review of the Technical file to assure conformity to the standard. Fameux medical will assist you in the selection of this Certifying Body, prepare the application and be present during the certification audit.
Fameux medical is a young Medical device consulting company in the Medical Device group.
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