Up until the time when I joined the RQS team in November all I had ever truly worked on was Quality. Coming out of college I worked for a plastics bottling manufacturer in process development and quality control. My next job was design V&V closely followed by design quality engineering and risk management. My exposure to regulatory affairs was at an arms length. I was always the person on the other end of a conversation where I was the one being told that I need to do something in a particular way because the regulations said so.
[fa icon="clock-o"] 2/19/13 6:11 AM [fa icon="user"] Ryan Kasun [fa icon="folder-open'] adverse events, Medical Devices, quality engineering, Regulatory Affairs, design quality, mhra, risk management, medical device, maude database, design dossier
Read More »One of the more personal aspects of why I work in regulatory and quality is because of my dad. As a youth, he experienced a hip injury. Combine that with a condition (don't ask - I never remember its fancy medical name) that causes weak capillaries, and that resulted in a "busted hip". Specifically, one that had become so painful in his late 30's he needed a hip replacement.
[fa icon="clock-o"] 1/18/13 4:09 AM [fa icon="user"] Ryan Kasun [fa icon="folder-open'] adverse events, hip replacement, surgery, safety communication, FDA, medical device, implantables
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