![]() It ensures the consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purpose. ![]() ISO 13485 was written to support medical device manufacturers in designing quality management systems that establish and maintain the effectiveness of their processes. ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. The new version of the Medical Devices standard: ISO 13485 2016 was published in March 2016 in response to several globally reported medical device product failures (for example, the PIP breast implant failures). What is ISO 13485 2016 (Quality Management Systems for Medical Devices) standard? ISO 13485 Medical Devices Quality Management Consultants in Gurgaon - List of ISO 13485 consultancy services, agencies, companies in Gurgaon and get ISO.
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