INSPECTIS AB, a global leading provider of advanced optical inspection solutions for the electronics and medical device manufacturing industries, has achieved ISO 13485 Certification, it is announced today. ISO 13485 is the standard for a Quality Management System for the design and manufacture of Medical Devices. Certification to the standard requires an organization’s quality management system to pass a third party Medical Device Single Audit Program, or “MDSAP” Audit.
ISO 13485 was written to support medical device manufacturers in designing quality management systems that establish and maintain the effectiveness of their processes. It ensures the consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purpose. INSPECTIS designs and produces digital optical microscopes and specialized devices used not only for the inspection of microelectronics and medical devices, but also for the examination and screening of diseases. ISO 13485 applies to companies in one or more stages of medical device production.