QA/RA Department

The purpose of the QA/RA department is to take care of our Quality Management System by constantly improve, develop and maintain it, to assure all processes throughout the whole organization is effective, suitable and adding value to the company and customer. The department is responsible for ensuring that LiNA Medical is fulfilling internal, customer, legal and regulatory requirements with the overall purpose of reducing the risk and increasing the safety of the patient and the user. The QA/RA department is also determining the facility QA objectives and activities for obtaining these as well as we are introducing TQM (Total Quality Management) to ensure good quality awareness amongst all employees at the company. Furthermore the department is taking care of all registration and re-registration of LiNA Medical products and components at various countries and areas of interest, incl. REACH.

LiNA Medical is certified in accordance with:

• EN ISO 13485
• The Medical Device Directive 93/42/EEC
• The Canadian ISO 13485

and is also FDA registered.