Technoline Ltd. has been granted ISO 13485:2016 certification for its Quality Management System (QMS). The company’s QMS was audited and certified by TuV Rheinland according to the requirements of ISO 13485:2016 standard.
This is a major milestone for Technoline Ltd. Our team has done a tremendous job in addressing all challenges with determination and persistence to get us here today, says Charlot Scicluna, Regulatory Affairs & Compliance Manager
ISO 13485:2016 is designed to respond to the latest quality management system practices for medical devices, including changes in technology and regulatory requirements and expectations. Being ISO 13485 certified means that Technoline Ltd. has implemented an ISO 13485 Quality Management System and has successfully met all of the requirements in ISO 13485:2016.
In the certification process auditors evaluated that Technoline Ltd’s Quality Management System is appropriate and effective while emphasizing the safety and efficacy of medical devices. As an ISO 13485:2016 certified company, quality, efficacy, and safety are part of our core activities. Technoline's personnel follow the procedures and rules required by the certification.
According to new MDR regulations, it is suggested that medical device economic operators such as Technoline Ltd; obtain a QMS certification. The new certification adds credibility for us in the market and a feeling of safety to our customers when purchasing and using our products and services.