Loading... Please wait...

CE Marketing for medical device and IVD

CE Marking for Medical Devices and IVD

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 or label as the evidence of compliance. Quality Workforce offers a complete list of services to assist the manufacturer in obtaining the CE mark for their products.

Our CE Marking Services Include:

  • Full management of the manufacturer’s regulatory affairs. Small or medium sized manufacturers can outsource all their regulatory activities to Quality Workforce experts for effective regulatory affairs management.
  • General consulting and training on the medical devices (MD) and in vitro diagnostics (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. Quality Workforce has developed an efficient system for risk analysis 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.
  • 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.

For a free no obligation quotation please call +1-416 919 9218 or complete the form and we will call you back.