Medical Device CE Mark Certification Consulting | Operon StrategistPosted by meeraoperon on December 12th, 2020 As CE marking certification consultants we help the new medical device manufacturers to bring forth their medical device in the EU that is the European market. And help with transitioning a current medical device Technical File to MDR. Our CE marking consultants go in depth of your device design, risk analysis, biological safety, clinical evaluation, testing reports, post market surveillance. CE mark on a product is mandatory it meets minimum legal requirements of the related directives which allow it to be placed legally on the market in any European member state. CE Mark Certification is a mark for Health, Safety and Environment protection standards to sell medical products in EEA (European Economic Area), CE mark is recognized worldwide. CE Mark is a declaration by manufacturers that, the products they are sell in EEA are meeting the requirements of EC Directives. In order to market products in the European market, the products must have a CE mark which declares that a product meets all relevant European Medical Device Directives. The benefit of CE certification is that it is a legal requirement to trade your device in the European market. CE Marking Consultant/ CE certification OverviewCE Mark is a Certification mark for Health, Safety and Environment protection standards to sell medical products in EEA (European Economic Area), CE mark is recognized worldwide. CE Mark is a declaration by manufacturers that, the products they are sell in EEA are meeting the requirements of EC Directives. In order to market products in the European market, the products must have a CE mark which declares that a product meets all relevant European Medical Device Directives. The benefits of CE certification is that it is a legal requirement to trade your device in the European market. The CE Mark is a 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.
What is CE marking for medical devices?CE mark shows that the device meets the legal requirements for medical devices. To place a CE mark on a medical device, the manufacturer must document the product’s quality, safety and performance. What is CE Mark Technical File or Design Dossier Compilation and Review?Compiling your technical file or design dossier is a critical step in Europe’s CE certification process and a requirement for compliance 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 Certification ProcessAn incomplete or improperly completed Technical File may result in unexpected delays or even prevent market entry. We Operon Strategist help you in the process of making a defined and comprehensive technical file with all product details required for CE marking. We also provide assistance in your process of making technical file and review it at every step for compliance with CE Mark. We have the technical expertise and experience to provide CE marking services. Our team supports clients in meeting “European submission” standards that declares the product offered is in compliance with the Essential Requirements of relevant European safety, health and Environmental protecting regulation. In order for your products to be placed on the European market, they must meet the requirements of the relevant product directives. We help you understand and meet these directives to ensure your product completes the CE Marking process efficiently and successfully.
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