The expertise of CE Medical is based on a combination of practical and theoretical knowledge in medical device certification, medical device safety, design engineering, quality assurance, technical documentation and the use of accredited test facilities. Our legal department covers all aspects of product liability and the legal consequences that arise from the European legislation for medical devices.
CE Medical is specialized in CE marking certification of medical devices and their related European Product Safety Regulations. CE Medicals’ team of experts fully supports designers, manufacturers, exporters, importers and distributors in order to ensure that they meet all requirements needed for compliance with European legislation for medical devices.
CE Medicals’ expertise also covers full practical support with regard to the private labelling of medical devices. We are able to assess the technical documentation from the Original Equipment Manufacturer (OEM) and make sure that the correct conformity assessment procedure is to be followed. Further, CE Medical is also able to draw up the Technical Agreement between the OEM and the Private Label Manufacturer (PLM), which is required when medical devices are brought onto the market via private label.
CE Medical works closely with the European Commission, as well as governmental bodies in all European Union member states. As a result, we are updated with the latest modifications related to European legislation for medical devices.
Aspects such as practical classification, determining the most efficient certification procedure, evaluation and verification of technical documentation, the compiling of technical documentation, ensuring correct testing of products, evaluation by affiliate notified bodies and registration of medical devices at the national authorities fall within the services of CE Medical. CE Medical will conduct the services in a custom made manner for any medical device.
CE Medical has subsidiary offices in China which have the expertise in house to ensure a successful and efficient certification of medical devices produced in China.