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. Certification provides a practical foundation for OEMs to address Medical Device Directives, regulations and responsibilities, as well as demonstrating a commitment to the safety and quality of medical devices. Excelitas develops precision lighting components that are used in some of these devices, among other applications.
Excelitas’ ISO 13485 certification demonstrates the company’s commitment to quality and certifies the business processes, including design and development, risk management, and production and service have been tested for effectiveness by an objective and internationally approved authority.
Jim Farrell, Excelitas Manager - Quality & Environmental Management Systems said, “This is a really important achievement for the organization, accomplished through the efforts of a dedicated team that managed the process while successfully continuing to operate our growing business at the same time. We’re very proud of their hard work and the recognition that our quality systems and business processes meet the highest quality standards for our customers’ vital products.”
Excelitas Technologies Corp. is a global technology leader focused on delivering high-performance, market-driven photonic solutions to meet the lighting, detection and other technology needs of global customers. From biomedical technology to research laboratory, safety and security, consumer, semiconductor, industrial, energy and environment, as well as defense and aerospace applications. Excelitas Technologies has approximately 5,500 employees in North America, Europe and Asia, serving customers around the world.