This is what we do

CellaVision develops medical devices 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, European regulations, American FDA quality system requirements, and several national directives and laws. CellaVision is responsible for the products being safe for patients, users, and technical service staff, and that is where the Quality department plays an important role.

At this department we…

• Are responsible for the registration of our products in countries where CellaVision intends to market our products or provide distributors with the documentation needed for registration.
• Make sure that CellaVision’s quality work complies with laws and regulations together with the team.
• Are a part of the planning and execution of clinical evaluations.