| Medical Devices
ZURKO RESEARCH
What kind of services do we offer?
ZURKO RESEARCH is a CRO providing consultancy service specialized in technical, legal and regulatory procedures for the medical devices (MD). Our services are aimed at medical devices and cosmetics manufacturing, sterilization, import and distribution companies. In the field of MD, we offer services covering the following areas:
CE marking
Advice on the necessary procedures for marking products in all risk classes (Class I, IIa, IIb and III)
Licensing
Support services for obtaining the Medical Device Operating License
ISO 13485
Advice on implementing a quality management system specific to medical devices
Non-clinical and clinical studies
The medical device CE-marking consultancy process involves performing a series of analytical services to develop and check the safety and quality of medical devices. At Zurko Research we perform non-clinical as well as clinical investigation at our facilities or collaborating with external sites (Hospitals, clinics etc.)
ZURKO RESEARCH
Medical Devices
Please contact us so that we can provide you with the information you require and adapt any of our studies to your needs
