To plan for CE Marking and to understand which a requirement needs to meet, you must contact CE Mark consultant team with good knowledge in the subject.
The CE Marking Consultants‘ team should help in the following areas.
- Device classification
- Identify the appropriate conformity assessment route for your medical device
- Identify the harmonized Standards
- Review the risk analysis File
- Conduct Clinical evaluation and prepare the report
- Post market Surveillance and Post market Clinical follow up
- Implementation of EN ISO 13485:2016
- Develop a Technical File
We have a pool of CE Marking Consultant from 2 to 21 years of technical Experience in medical device CE Marking. The CE Marking Consultants teams allow you to build reliability and confidence into your CE mark project.