The requirements and process approach are relevant to any regulated organization that designs and develops, produces, installs or services medical devices or provides related services. The guidance standard ISO/TR 14969 provides approaches to establish objectives, implement, monitor and measure the processes to improve performance. The ISO 13485 and ISO/TR 14969 Quality Management Systems Medical Devices Package specifies the requirements and procedures to implement a quality management system for an organization that needs to consistently meet regulatory requirements applicable to medical devices and related services. The ISO 13485 standard was published by the International Standards Organization to provide medical device companies with requirements for establishing and maintaining quality systems. Most recent ISO 13485 and ISO/TR 14969 Quality Management Systems Medical Devices Package ISO 13485 and ISO/TR 14969 Quality Management Systems Medical Devices Package ISO 13485 CERTIFICATION IS A REQUIREMENT FOR MEDICAL DEVICE COMPANIES THAT WISH TO MARKET THEIR PRODUCTS IN EUROPE AND AROUND THE WORLD.
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