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.
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.
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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