The EU Directive 2007/47/EC emphasizes the need for clinical data and clinical evaluation for medical devices intended to be CE marked. Guideline MEDDEV 2.7/1 revision 4 has further raised the compliance bar.
We can help you with:
Clinical evaluation reports
Appraisal of clinical data
Analysis of clinical data
Reviewing clinical evaluation reports
Contact me for further information Nils-Åke Lindberg
Office +46 46 286 88 90 or send me an e-mail