Quality Systems for Medical Device Producers and Distributors
Medical device producers was forced to build a quality system and to certify it to meet legal obligations, to increase their productivity and to create legal assurance for potential cases in the process of adapting to European Union directives. In Europe and after the date of 13 September 2003, this study keeps to put CE sign mandatory. 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 requirements and regulatory requirements applicable to medical devices and related services.
The primary objective of ISO 13485:2016 is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001.
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