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.
Consulting
Quality Management Systems Consulting Services
Whether you’re new to the market or an established company, Winovia is your partner for auditing, developing and implementing effective, compliant and usable quality management systems. We have the experience to help you address and remediate regulatory non-compliances. Winovia can guide you through developing systems and procedures for design controls, risk management, process validation, supplier quality management and more.
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Training
Quality Training for Medical Device Manufacturers
Winovia provides customized in-house training for medical device manufacturers, contract manufacturers and their suppliers. Winovia’s training is tailored to your company’s unique systems and products to create highly knowledgeable workforce.
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Plastics in Medical Devices
3rd Edition by Dr Vinny Sastri
A comprehensive survey including applications, production, unique properties, and techniques to enhance properties with examples of real-world use. Includes chapters on Process Validation and Supplier Controls.
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Focus on the Latest Regulatory and Risk Management Requirements for Medical Plastics
Here are the new, key regulatory and risk management requirements for plastics and additives used in medical devices, from design all the way to use.
How to Reduce Risk As Far As Possible
How to identify and analyze risk control options and implement those risk control measures that reduce risk as far as possible, without adversely affecting the benefit-risk ratio.
European Union Medical Device Regulation (EU MDR) and Risk Management — Reduce, Eliminate, Minimize, Remove or Avoid Risk?
Learn about the updated EU MDR’s strong emphasis on safety and risk management.
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