CE marking

In Vitro Diagnostics or Medical devices that are placed on the European market, must meet the requirements of their respective European Directives and Regulations. Conforming products will receive the CE mark as the evidence of compliance.

Qarad offers a complete list of services to assist the manufacturer in obtaining the CE mark for his products.

These services for CE marking include:

Full management of the manufacturer’s regulatory affairs. Small or medium sized manufacturers can outsource all their regulatory activities to Qarad’s experts for effective regulatory affairs management.

  • General consulting and training on the In Vitro Diagnostics (IVD) and Medical Devices (MD) Directives and Regulations and their impact on your business and operations.
  • Practical training sessions on specific parts of the Directives and Regulations, such as risk management and the composition of technical documentation. Qarad has developed an efficient system for risk assessment and makes document packages available for the creation of technical documentation and for facilitating conformity assessment.These sessions will help you understanding all requirements for CE Marking.
  • Review of your technical documentation to identify any deviations from the regulatory requirements.
  • Composition of technical documentation and design dossiers for notified body assessment.
  • Review of your Instructions for Use and product labels. Advice in the design of labeling and optimization for translation. 
  • Audit (gap analysis) of your quality system versus the Directives or Regulations' quality system requirements and ISO13485.
  • Assistance in notified body selection and in the preparation for a conformity assessment by the notified body.
  • Advice in the classification of medical devices and borderline products.
  • Organization of performance studies for In Vitro Diagnostic products, according to the applicable standards (Common Technical Specifications, CLSI standards, WHO standards,...)
  • All interactions with the competent authorities.
  • Support in the case of regulatory actions by authorities versus manufacturers or products in the market.
  • Management of incidents: incident notification, recall, editing of advisory notices.
  • Literature based scientific validity reports and clinical evaluations reports

Contact us for more information about obtaining the CE Mark.

CE marking
« On behalf of Wondfo, thank you so much for your great help in CE Mark during the past year. Without your professional and kind services, we would not have our first CE Mark so smoothly. All of us enjoy working with you, ‘Dr. Dirk’ has become very popular among Wondfo and we are looking forward to more co-operations with you. »

Guangzhou Wondfo Biotech Co. Ltd
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