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A quality management system (QMS) is defined as a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives.  A QMS helps coordinate and direct an organization’s activities to meet customer and regulatory requirements and improve its effectiveness and efficiency on a continuous basis.

Equipment validation is a term used to describe a set of independent procedures that are used to check if a product meets the specifications and requirements of its intended purposes.  Regulatory agencies around the world have strict requirements for quality, procedures, performance testing and safety checks, for a wide range of products.

Whether in a hospital, doctor office, university or clinical engineering setting, medical devices and specialty equipment are vital to developing successful procedures and treatments.  It’s not just important that healthcare equipment records be properly maintained, it is a legal requirement in certain settings.