-Operon Strategist ISO 9001,ISO 13485 consultant for medical device manufacturers. -Operon Strategist are providing ISO 13485 consulting service for medical device manufacturers.ISO 13485 is a quality system standard designed for medical device companies. The international quality management systems for the design and manufacturers of medical devices can help company stand out.
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ISO 13485 is where an organization needs to demonstrate its ability to provide medical devices and related services consistently meet customer requirements and regulatory requirements. http://www.omnex.com/training/iso13485/iso13485-medical-devices-fda-cfr-21-training.aspx
iso 13485 certification is just like a tools for increase the manufacturing process and procedure with reducing risk. this standard help to provide effective quality assurance. URS provide iso 13485 certification in all india.