Neil Buckley Executive Resources
Neil Buckley Executive Resources
Medical Device Consultants

REGULATORY

CE MARKING

NBER can call upon experts in all three EU medical device directives; Medical Devices, Active Implantable Medical Devices and In Vitro Diagnostics.

We can provide assistance and advice with:
Defining the appropriate CE Marking routeTechnical File/Design Dossier development Quality Management SystemsChoice of Notified Body

CLINICAL EVALUATIONS

The revision of the medical devices directive (2007/47/EC) puts a greater emphasis on clinical data to support the use of devices. NBER can provide help in meeting the requirements through systematic reviews of clinical and scientific literature.