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Regulatory and Quality Solutions

(877) 652-0830|http://www.rqteam.com/

September 2018

R&Q Webinar: Wait, what? That’s a combination product?

September 25 @ 1:00 pm - 2:00 pm
Webinar Online Event, OH United States

Join BioOhio member R&Q for a webinar on September 25 at 1pm. Is there a medical device hiding in your product portfolio? Combination products – defined in 21 CFR 3.2(e) – are often stealthy, and once you’ve discovered one, do you know what to do? This webinar will answer those questions and more. After defining what constitutes a combination product and examining other vital basics, we’ll share numerous case studies that shed light on how other companies of different sizes…

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October 2018

R&Q Webinar: Understanding EU MDR and the Roadmap to Compliance

October 23 @ 1:00 pm - 2:00 pm
Webinar Online Event, OH United States

Join BioOhio member R&Q for a webinar on October 23 at 1pm. The EU MDR date of application is approaching faster than you might think. With changing schedules and increased scrutiny from the notified bodies, as well as an overwhelming amount of information out there, it can be difficult to understand the impact of the new regulations and determine where and when to start. Your technical files, design dossiers, quality system documents, clinical plans, labeling (including UDI), software, and more…

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November 2018

R&Q Webinar: Economic Operators

November 27 @ 1:00 pm - 2:00 pm
Webinar Online Event, OH United States

Join BioOhio member R&Q for a webinar on November 27 at 1pm. The EU MDR extended the responsibilities of those who handle your information and product, and require you have new systems to interact with them throughout the process. In this webinar we will cover the requirements for authorized representatives, importers, and distributors. We'll also cover what you as the manufacturer need to do to ensure that these entities are prepared and ready for implementation. Key webinar takeaways: Your role…

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