Sophysa

QUALITY ASSURANCE

Quality Management

Sophysa Quality Management has been certified since 1996. (ISO13485)

All medical devices bear their CE marking, mainly due to Design Examinations passed with success.

Certification and CE Mark are both issued by the French Notified Body G-MED (Groupement pour l'Evaluation des Dispositifs Medicaux Médicaux, CE0459)

European Medical Devices Certification

Products	MDD Classification*	MDD Rule*	EC Certificates and Declaration of Conformity
Sophysa Neurosurgery Devices
Valves	III	8
Catheters	III	8
Reservoirs	III	8
External Drainage System	IIa	7 & 2
Implantation Accessories	I or IIa	6
Valves Adjustment Systems	I	6 & 1
Sophysa Chemotherapy Devices
Soph_a_Port®	III	8
Sophysa Vascular Surgery Devices
Carotid Shunts	III	6
Sophysa Neuro Monitoring Devices
Pressio® Monitor/Interface	IIb	10
Pressio® IPC Monitoring Catheters	III	7
Monitoring Implantation Accessories	I & IIa	1 & 6

*MDD = Medical Device Directive 93/42/EEC dated 06/14/93.

American FDA Clearance

The Sophy® Adjustable Pressure Valve is 510(k) cleared as K013488.
The Polaris® Adjustable Pressure Valve is 510(k) cleared as K031097.
The Polaris® Adjustable Pressure Valve models with special pressure
K042481.