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.
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.
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.