Qserve America

(advanced) Woundcare products
Non-wovens/ gauzes	IIa	yes	yes	yes	yes	yes
Wound dressings for severe and chronic wounds	IIb	yes		yes	yes	yes
Hemostats agents	III		yes	yes	yes	yes
Medical devices with animal tissue derived components	III		yes	yes	yes	yes
Dental products
Dental implants and accessories	IIa & IIb	yes		yes	yes	yes
Tooth whitener	IIa	yes		yes	yes
Surgical products and accessories
Design and development of (micro mechanical) medical devices					yes	yes
HA-Coated Implants	III			yes	yes	yes
Surgical Mesh	IIb	yes		yes	yes	yes
Cardiac surgery devices	IIb & III		yes	yes	yes
Blood circulation system custom packs	IIa		yes	yes	yes	yes
Contraceptive products
Intra uterine devices	III	yes		yes	yes	yes
Contraceptive products	IIb			yes	yes	yes
Combination products (borderline)
Heparin coated products	yes				yes	yes
Preventive / Treatment supporting products
Blood measurement and beat to beat haemodynamic monitoring systems	IIa	yes	yes	yes	yes	yes
Anti-decubitus mattresses and cushions	I			yes	yes
Training & courses
Half a day / introductory	yes	yes	yes	yes	yes*	yes
One day courses	yes	yes	yes	yes	yes *	yes
One day courses + QSR			yes
Two day extensive training	yes	>>	>>	yes	yes *
In-house training	yes	yes	yes	yes	yes	yes
* in cooperation with the Dutch Standarization Institute

Title	CE marking approvals (Classifications)	MDR CAN/CSA	510(k) or others	(EN) ISO 14971	(EN) ISO 13485	Biocomp & safety studies/ management ISO10993

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