Services » CE marking

CE marking

Medical devices or in vitro diagnostics that are placed on the European market, must meet the requirements of their respective European Directives. 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 MD and IVD Directives and their impact on your business and operations.
• Practical training sessions on specific parts of the Directives, such as risk analysis and the composition of technical documentation. Qarad has developed an efficient system for risk analysis and makes document packages available for the creation of technical documentation and for facilitating conformity assessment.
• 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. Advise in the design of labeling and optimization for translation. Translation of your instructions for use through our network of specialized translators.
• Audit (gap analysis) of your quality system versus the Directives’ quality system requirements and ISO13485.
• Assistance in notified body selection and in the preparation for a conformity assessment by the notified body.
• Advise in the classification of medical devices and borderline products.
• Organization of performance evaluations for in vitro diagnostic products, including Annex II products and self-testing products.
• Assistance in the composition of clinical data and the organization of clinical investigations for medical devices.
• All interactions with the competent authorities.
• Notification of CE marked products to the national 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.

Contact us for more information.

« 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. »