Medical device manufacturers face many challenges in order to manufacture innovative, high-quality goods that also comply to FDA regulations and ISO quality system requirements. Quality in the medical industry cannot completely be managed effectively with conventional document-centric quality management tools.
Processes for quality control and manufacturing are connected by HQA 360’s product-centric quality management system (QMS). With one reliable source of truth, compliance to regulations is made easier, transparency is improved, and production is increased.