It happens multiple times a year when I interact with pharma, biotech, or medtech clients. We start discussing computerized system use and data integrity, and inevitably, I hear some variation of: “Our electronic data is...
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Four Key Considerations for Medical Device Quality Assurance in October As October ushers in the festive spirit of Halloween, with costumes, candy, and chilling thrills, this spooky season shouldn’t seep into the world of medical...
Read MoreA Personal Story of Impact & Loss On September 18, 2020, 4 years ago, as a few of my LinkedIn connections know, a close colleague and friend of mine disappeared. One day we were WhatsApp-ing...
Read MoreThe health and safety of athletes are super important during any sporting event, especially at the Olympic Games, where the stakes are high, and the competition is intense. In recent years, technological advancements have enabled...
Read MoreIt’s my birthday month, and as we typically do , I have taken time to be introspective about where I have been and where I am going. From 2001 to 2020, I was the Head...
Read MoreHappy Father’s Day to all the wonderful fathers out there! In the world of quality management, one name stands out above the rest – Dr. W. Edwards Deming, often regarded as the “father of quality...
Read MoreIt’s 1995, and I’m ready to lead the charge in implementing ISO 13485 and the new Quality System Regulation. I am new to the quality system game, as are we all – it has been...
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