Medical Device Directory

ISO Compliance

Available from mdi Consultants, Inc.

ISO is a set of global quality standards that are geared to companies providing products or services as a framework for achieving customer satisfaction through implementing a quality management system. The ISO set of standards have become an important mechanism to allow companies to inform their customers and competitors that they have implemented an externally-accepted quality system in addition to enabling companies to increase conformity and efficiency in their operations. ISO is continually increasing its global presence and becoming a regulatory requirement for many industries.

mdi Consultants has assisted over 150 companies achieve ISO compliance across a wide array of ISO standards (e.g. ISO 9001:1994, ISO 9001:2000, ISO 13485 (EN 46001), ISO 13488 (EN46002)). We have guided many companies across the following industries: medical device, pharmaceutical, clinical research organizations (CRO), food and other manufacturing (e.g. parachute manufacturer, aerospace, defense). Our customer testimonials will provide you a glimpse of the experience of working with mdi on ISO. In addition, mdi guarantees, if you follow our program, you will achieve ISO compliance on your first audit by a certifying registrar.

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