CE Mark ... the EU logo and a whole lot more!
More than ever before you need expert advice on navigating EU regulatory compliance and CE Certification regulatory maze on such important items as:
- EU harmonized standards demonstrating regulatory compliance to the essential requirements
- Usability studies
- Clinical Evaluation
- ISO 13485 based quality management system
- Labelling and instructions for use including translation, symbols and contraindications and warnings
European regulatory compliance, the second most important regulatory certification after a FDA 510(k)! Horizon Phoenix experts have helped more than 600 companies get thousands of products EU CE Marking. Products such as in vitro diagnostic test kits, digital radiography equipment, sterile surgical gloves, artificial organs, drug/device combinations, long-term implantables and many others. Every risk class, every major configuration, disposable, reusable, sterile, non-sterile - Horizon Phoenix has the EU regulatory compliance experience you need.
Don't get half way through your CE Certification testing only to find out you are headed in the wrong direction!
Ask Us How to make CE Mark Certification fast and easy!
More good news on regulatory compliance - CE Mark regulatory compliance can be used as a great starting point for an FDA 510(k). If you organize your regulatory compliance activities properly you can demonstrate compliance to many jurisdictions.