Winovia® LLC is a consulting and training company that provides customized solutions and strategies for organizations to streamline and transform their new product development systems, quality systems and manufacturing processes. We also align organizations’ Quality Management Systems with specific regulations and standards like the US FDA and ISO regulations and standards. Client companies achieve organizational and operational excellence leading to sustained growth and profitability.

Winovia is your expert partner for ….

New Product Development Systems

Winovia can help you assess your New Product Development process, identify weaknesses and strengths, and create and implement a customized system for creating and managing new products through their entire life cycle.

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Operational Excellence & Quality Management

Winovia is your partner for auditing, developing and implementing sustainable and compliant quality systems and manufacturing processes. Winovia’s systems and training result in operational efficiency, productivity and superior quality.

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FDA/ISO Compliance & Quality Systems

Whether you’re new to the market or an established company, Winovia has the expertise to help you develop effective, sustainable and compliant quality systems. Winovia has the knowledge to help you address Warning letters and FDA Form 483s, as well as implement procedures for design control, risk management, complaint handling and CAPA.

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UPCOMING EVENTS

May 16, 2012
Dr Vinny Sastri will be presenting Best Practices in Implementing an Effective Risk Management System at the Medical Device Quality Conference in Bethesda MD. For more information click here.

May 21, 2012
Dr Vinny Sastri will be presenting Process Validation: Solutions and Strategies for the Medical Device Industry at the Medical Design and Manufacturing (MD&M) East Conference in Philadelphia, PA. For more information click here.

RECENT EVENTS

April 26, 2012
Dr Vinny Sastri presented Developing Medical Devices for Manufacturability at BIOMEDevice Boston. 

Feb 13, 2012
Dr Sastri led a day-long workshop  Process Validation: Solutions and Strategies for the Medical Device Industry at MD&M West in Anaheim, CA.

September 22, 2011
Dr Sastri has been appointed as Director of Design Quality Assurance at TERUMO CVS.

June 13-16, 2011
Dr Sastri was one of the trainers for FDA Quality System Requirements, a 4-day intensive training in Nashville, TN for the medical device industry sponsored by AAMI.

June 8, 2011
Dr Sastri presented the full-day interactive session Process Validation: Solutions and Strategies for the Medical Device Industry at MD&M East in New York City.

June 9, 2011
Dr Sastri presented the full-day interactive session Advanced Process Validation at MD&M East in New York City.

Archive of Past Events