ClearView Endoscopy are very pleased to announce they are ISO 13485 certificated – reviewed and issued by Lloyds Register Quality Assurance (LRQA), the leading international provider of quality management systems and their certification.
ISO 13485 certification promotes harmonisation of regulatory requirements for manufacturers of medical devices on an international scale.
A number of countries have incorporated ISO 13485 into their regulatory systems. Compliance with ISO 13485 can be used in support of regulatory compliance. It incorporates many of the quality management principles and delivers the benefits of an ISO 9001 based quality management system.