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Medical device and IVD equipment manufacturers mostly operate within the boundaries of a quality system, which complies with one or more of the international harmonized standards. Those systems are subjected to audits as part of the certification process and regulatory compliance. Internal audits performed by external bodies are a great way to control and maintain QMS activities.

Any company that wants to manufacture or import medical devices in Argentina must have a Quality Management System in compliance with ANMAT's GMP. ANMAT GMP QMS System Implementation, Anmat GMP QMS System Implementation.