Winovia® LLC provides customized strategies and training for medical device manufacturers, contract manufacturers and suppliers to the medical device industry. We align organizations’ Quality Management Systems (QMS) with specific Quality System Regulations (QSR) and current Good Manufacturing Processes (cGMP) like the US FDA, EU MDR and ISO regulations and standards. Clients achieve operational excellence leading to better quality, sustained growth and profitability.
With the explosion of medical devices and manufacturers, a need was realized to develop a medical-device-specific standard based on ISO 9001. The result is ISO 13485.
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