Iso 13485 Certification Services - Quality Management System For Medical Device Compliance, Streamlined Iso 13485:2003 Certification Process

Enlisted in reputed and trusted companies, we are engaged in offering ISO 13485 Certification Services in Lucknow, Uttar Pradesh, India & across the world. ISO 13485:2003 specifies requirements for a quality management system that can be used by an organization for the design and development, production, installation and servicing of medical devices, and the design, development, and provision of related services. This is a process-based system and contrasted to the procedure-based system of QSR and ISO 9001. Manufacturers of Medical Devices are subject to specific legislative fulfilments. Medical Devices intended for diagnostic or therapeutic use, must comply with stringent requirements for safety and effectiveness .The medical device industry throughout the world will move toward adopting the new ISO 13485:2003 as the preferred quality system standard.