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October 2018

NAMSA Webinar: EU MDR – General Safety & Performance Requirements for the Biocompatibility of Medical Devices

October 23 @ 11:00 am - 12:00 pm
Webinar Online Event, OH United States

Join BioOhio member NAMSA for the webinar EU MDR - General Safety & Performance Requirements for the Biocompatibility of Medical Devices. Are you preparing to upgrade your device technical documentation to meet the European Union’s (EU) Medical Device Regulation (MDR) 2017/745 General Safety and Performance Requirements? If so, this webinar will provide best practices and meaningful tips for manufacturers with devices sold under CE marks. NAMSA EMEA regulatory expert, Vincent Legay, will explain how the EU MDR requirements supersede current…

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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

IVD Clinical Trials – Essential Components for Product Launch in 2019 & Beyond

November 6 @ 10:00 am - 11:00 am
Webinar Online Event, OH United States

Join BioOhio member NAMSA for a webinar on 11/6 at 10am. Webinar Description: As in vitro diagnostic (IVD) markets and regulations change, it’s imperative to stay up-to-date on clinical trial components that are required to facilitate efficient, cost-effective market approvals. During this NAMSA-sponsored webinar, Kristin Jones, MS, CCRA (Principal Medical Research Manager), will discuss the essential mechanisms that must be addressed throughout IVD clinical studies regardless of product type or intended market launch territory. Highlighted will be: An overview of…

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Webinar: Use Ohio TechNet’s Consortium to Build your Talent Pipeline

November 15 @ 10:00 am - 11:00 am
Webinar Online Event, OH United States

Join The Ohio Manufacturers' Association for the webinar Use Ohio TechNet’s Consortium to Build your Talent Pipeline on November 15 at 10 am. Ohio TechNet is a statewide consortium of 27 colleges/universities focused on accelerated training to meet the needs of Ohio’s manufacturers. This collaborative initiative launched with 11 colleges in 2014, training about 2,300 transitioning adults for careers in manufacturing. Participation of additional colleges and universities expands Ohio TechNet’s capacity to recruit and train your future workforce. Join us for this…

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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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