Quality Management
Systems Consulting

Whether starting from scratch, remediating or fine tuning your Quality Management Systems, Winovia is your partner in the ever-changing landscape of FDA / EU MDR / ISO regulations.

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.


FDA Sign

Medical Device Regulations Part 1 — USA

Since 1906, the US FDA has sought to ensure the safety and efficacy of medical devices. This article outlines the history and rationale that created the Quality System Regulation for Medical Devices 21 CFR Parts 820.

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