Medical Device Development

CE-Mark Application

Products in compliance with all provisions of the applicable directives providing for the CE marking must bear this marking. The CE marking is an indication that the products comply with the Essential Requirements of the medical device directives and that the products have been subject to a conformity assessment procedure provided for in the directives.

The following is the flow-chart for Medical Device Development

We can support you for all steps of Medical Device Development:

• Identification of Applicable Directives and Guidance on the necessary steps to receive the CE-mark

• Preparation and Review of the Device Technical File according to MDD 2007/47/EC and applicable Standards

• Clinical Evaluation according to ISO 14155

• Risk Analysis according to ISO 14971

• Negotiation with Notified Bodies and Ministry of Health

• Clinical Trials set-up and monitoring

• Post-market surveillance and reporting

  
  

For further information please refer to our web dedicated to Medical Device