CellaVision develops medical equipment in a highly regulated environment. The company is certified under the quality standard ISO 13485 and complies with the requirements of international legislation and product safety standards, such as IEC standards, the European Directive on in vitro diagnostics (IVD), American FDA quality system requirements and a number of national directives and laws. CellaVision is responsible for the products being safe for patients, users and technical service staff.
The Quality department consists of three teams; Regulatory Affairs, Quality Assurance and Clinical Affairs. Regulatory Affairs is responsible for registration of our products in countries where CellaVision intend to market our products or provide distributors with documentation needed for registration The RA team is also responsible for forwarding country specific requirements to QMS and product requirements. Quality Assurance is responsible for maintaining the QMS needed to fulfill the requirements we have committed to. Finally, the Clinical Affairs team is responsible to assure that the products we market have undergone sufficient clinical evaluation. The CA team is also responsible for planning and execution of clinical evaluations.
