The CE Mark is conformity mark which all medical devices must have before they can be marketed. It is seen as a declaration by the manufacturer that the product meets all the provisions of the relevant directive. Devices are classified based on their contact with the body & the duration of contact.
Our Service range includes CE Mark certification consultancy services. CE marking – In order to market products in the European market, the products must have a CE mark which declares that a product meets the CE directives.
Experienced industry professionals are handled CE Requirement services by who have necessary knowledge as well as in-depth knowledge of meeting the demands of CE Mark Certification.
Our team supports clients in meeting “European submission” standards that declares the product offered is in compliance with Essential Requirements of relevant European safety, health and Environmental protecting regulation.
We Are Leading Medical Device CE Marking Certification Consultant Service provider for Medical Device disposable implant Manufacturers , Medical Disposable syringe Manufacturers , Medical Devices and Surgical Instrument Manufacturers , Orthopadic Implant &instruments Manufacturers , Laboratory Equipment Manufacturers , Sterilization Equipment and Accessories Manufacturers, Medical Imaging systems Manufacturers.
CE Technical File or Design Dossier Compilation and Review:
A CE Marking Technical File or Design Dossier (Class III) is a Containing depiction of your gadget intended to show consistency with European requirements. Compiling your specialized record or plan dossier is a basic advance in Europe’s CE Marking process and a necessity for consistency with the Medical Devices Directive 93/42/EEC, In Vitro Diagnostic Medical Devices Directive 98/79/EC, or Active Implantable Medical Devices Directive 90/385/EEC.
CE Marking technical file or dossier incorporates definite data about the design, function, composition, use, claims, and clinical evaluation of your medical device. They are required for all classes of devices (Class I, I Measuring, I Sterile, IIa, IIb and III) however no two records are the same on the grounds that the kind of gadget directs the data included in that.
Reference Documents & Tutorials
CE Marking Regulatory Guidelines Click Here