CONTACT WITH COMPETENT AUTHORITIES AND 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.

• 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)