Customized regulatory support for all medical devices
Our customers value us for our practical approach, our international focus and or broad and specific expertise. Qserve is the one stop partner for all compliance projects with the final goal: getting their product on the international market.
Challenges with the Notified Body, CAPA system, resources for global registration, maintenance of technical files, preparation of Clinical Evaluation Reports.
Challenges with regulatory requirements and in need of a partner that can assist with all compliance issues, from
strategy to market approval.
Lack of resources and hands-on expertise
for further product development and network for compliance with
Wound dressings for chronic wound care, with hydrogels and for compression therapy
Devices for coronary artery, peripheral vascular and carotid artery diseases
Coated and impregnated devices, coated balloon catheters and bone cements
Standalone or as part of a medical device to diagnose, monitor, control or inform
Pacemakers, defibrillators, implantable stimulators, sensors and neuro stimulators