Contact with notified bodies
In order to obtain a CE mark you need to set up a quality system, ensure that risk management and vigilance systems are in place and that your staff are trained on relevant procedures.
Make an appointment
Liaise with Competent Authorities and Notified Bodies during both the pre and post market phases
Set up a functioning quality system based on ISO 13485
Set up a functioning risk management system based on ISO 14971
Ensure regulatory compliance before an audit (pre-audit your facility)