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Regulatory Affairs

EU MDR: Your Questions, Our Answers

On May 5, 2017 the EU MDR (Medical Device Regulation) was published in the EU Official Journal. This date starts the three-year mandatory transition period where the MDR will replace the MDD (Medical Device Directive). The expanded scope of the MDR combined with the time frames for compliance is compelling medical device companies to focus significant attention on transition strategies and will require substantial hands-on work. R&Q recently presented the webinar, EU MDR: Assessing the Impact and Next Steps. During the session we answered several of your questions, a sample of which are below. To see all of the questions and answers from the session, along with the slides and recording, check out the on-demand webinar.
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adverse events

Regulatory Thoughts

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.
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Medical Devices

Medical Devices and Fantasy Football, More in Common Than You Think

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.
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Labels impact the device

During this holiday season, when presents are being packaged and shipped at high volumes, I thought it would be appropriate to talk about the importance of labeling.
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