Gecko Biomedical, a French medical device company developing innovative polymers in the form of sealants and adhesives for wound closure, recently announced that it has received the ISO 13485:2003 certification for the design and development of its state-of-the-art technologies.
The international notified body Lloyd’s Register recorded and approved the company’s compliance with the quality system regulatory requirements, its control of special processes and the risk analysis along the products value chain.
About ISO Standards
ISO 13485 is a standard for measuring the quality of instruments and medical equipment as well as that of medical technologies. This standard defines the requirements linked to quality management systems and quality assurance systems related to the design, development, production, installation and maintenance of medical devices. This standard may be used internally or by third parties, particularly certification bodies, to assess an organization’s ability to answer both regulatory and customer requirements.