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.
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.
Tollgate Reviews and Design Reviews are both vital elements of product development, but many companies confuse the two. Here’s the difference.
Integrating Medical Device Product Development, Design for Six Sigma and Quality Systems Requirements – Part 1
How to harmonize Quality System Requirements and DfSS with your New Product Development Process, Part 1…
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