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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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MDMA 21st Coverage, Reimbursement & Health Policy Conference

November 7 - November 8
Hogan Lovells US LLP, 555 13th Street NW
Washington, DC 20004 United States
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MDMA’s 21st Coverage, Reimbursement and Health Policy Conference is being held in Washington, DC on November 7-8, 2018. MDMA has assembled a dynamic group of speakers and informative sessions for this year’s conference that will share the latest approaches on how to demonstrate value for your medical technologies and what type of clinical data will ensure you secure fair and adequate reimbursement. TOP SESSIONS INCLUDE Interactive Case Studies Analysis CMS Ombudsman Session Shifting from Volume to Value Local Coverage Process…

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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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December 2018

Cybersecurity in Medical Devices presented by BioOhio

December 5
Nationwide and Ohio Farm Bureau 4H Center, 2201 Fred Taylor Drive
Columbus, OH 43210 United States
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There are millions of digitally connected medical devices in use today. Research predicts that the market for healthcare-related Internet of Things (IoT) products will be worth over $136 billion worldwide by 2021. Throughout the medical device industry, manufacturers are developing products that include cutting-edge technology linked to online networks or integrated with other medical devices. This IoMT (Internet of Medical Things) event will feature medical device and diagnostics professionals discussing their challenges and opportunities with networked medical device design, governance,…

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March 2019

2018 Molecular Medicine Tri-Conference

March 10, 2019 - March 15, 2019
Moscone Center, 747 Howard Street
San Francisco, CA 94103 United States
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Join over 3,700 drug discovery, development & diagnostics professionals worldwide at the 26th International Molecular Medicine Tri-Conference! Since its debut in 1993, the annual Molecular Medicine Tri-Conference has become one of the world's leading international events in the field of drug discovery, development and diagnostics. The Tri-Conference unites an ecosystem of 3,700 innovative thinkers and thought leaders throughout biotech, pharma and academia from around the world. Spanning five days, the 2019 Tri-Conference includes compelling talks, including case studies and joint…

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2018 Bio-IT World West Conference & Expo

March 10, 2019 - March 15, 2019
Moscone Center, 747 Howard Street
San Francisco, CA 94103 United States
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Bio-IT World Conference & Expo has established itself as a premier event showcasing the myriad IT and informatics applications and enabling technologies that drive biomedical research, drug discovery & development, and clinical and healthcare initiatives ... and now the Bio-IT World Expo is on the West Coast! Join us for compelling talks, including best practice case studies and joint partner presentations, from your fellow industry and academic colleagues discussing themes of big data, smart data, cloud computing, trends in IT…

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