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Practical expertise on legal and technical issues in the field of Medical Device legislation
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CE Medical with subsidiary offices in China is an international technical and legal certification organization with expertise in the certification of medical device products. CE Medical is specialized in CE marking certification of medical devices and their related European Product Safety Regulations. CE Medicals’ team of experts fully support designers, manufacturers, exporters, importers and distributors in order to ensure that they meet all requirements needed for compliance with European legislation for medical devices.
The expertise of CE Medical is based on a combination of practical and theoretical knowledge in medical device safety, engineering, quality assurance, technical documentation and the use of 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 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. This makes a practical and visible certification procedure to ensure a successful and efficient certification of a medical device.
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 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.