How much time to you spend searching FDA’s website? Looking for predicates, collecting adverse event reports from the MAUDE database, searching for guidance documents, etc. I’m sure I don’t need to dig into the details, you have felt this pain too if you have spent any appreciable amount of time on the www.fda.gov. Albeit a great source of information, it is a complex web of blue pages, and it takes a very large amount of time (and money!) to find the information you are looking for.
[fa icon="clock-o"] 6/14/13 9:13 AM [fa icon="user"] Ryan Kasun [fa icon="folder-open'] software system, regulatory focus, www.fda.gov, FDA, FDA website, maude database, software, regulatory, Graematter, Regulatory Intelligence
Read More »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 »I constantly find myself trying to draw parallels between my work life and personal life in almost everything I do and while I work in Quality and Regulatory for medical device manufacturers, I enjoy spending downtime playing fantasy football. Being that this weekend was the Championship round for the NFL I began some reflection. I found myself realizing that fantasy football has similarities to writing a technical file for a medical device.
[fa icon="clock-o"] 1/21/13 8:13 AM [fa icon="user"] Ryan Kasun [fa icon="folder-open'] Medical Devices, Regulatory Affairs, medical device manufacturers, maude database
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