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NAMSA

(419) 666-9455|https://www.namsa.com/

April 2020

NAMSA Webinar: Optimizing Electronic Data Capture (EDC) for IVD Clinical Trials

April 8 @ 11:00 am
Webinar Online Event, OH United States

Join BioOhio member NAMSA on April 8 at 11am for the webinar Optimizing Electronic Data Capture (EDC) for IVD Clinical Trials. Unlike medical devices, In Vitro Diagnostic (IVD) clinical studies tend to generate a higher number of patient data points such as sample enrollment and instrument data. Optimizing and structuring an Electronic Data Capture (EDC) system to manage these large data sets is often a challenge as it requires heavy planning and preparation during the EDC and Case Report Form (CRF)…

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NAMSA Webinar: Do’s and Dont’s for Early-Stage IVD Product Development and Risk Mitigation

April 22 @ 11:00 am - 12:00 pm
Webinar Online Event, OH United States + Google Map

Join BioOhio member NAMSA on April 22 for the webinar Do's and Dont's for Early-Stage IVD Product Development and Risk Mitigation. A well-planned approach to navigate the early stages of In Vitro Diagnostic (IVD) development will yield significant competitive advantages by shortening time-to-market without additional costs. Robust plans that include factors such as market opportunities, regulatory requirements and demonstration of product safety/efficacy can effectively impact development timelines and costs. Join NAMSA for this webinar and discover how to navigate a variety…

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May 2020

NAMSA Webinar: Current Opportunities and Challenges with Clinical Data Under EU MDR – A NAMSA Panel Discussion

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

Join BioOhio member NAMSA on May 6 for the webinar Current Opportunities and Challenges with Clinical Data Under EU MDR - A NAMSA Panel Discussion. Join NAMSA’s Regulatory experts for this panel discussion to review current opportunities and challenges faced in the medical device industry today with the impending EU Medical Device Regulation (MDR) compliance deadline. Topics to be covered during this webinar include: Sufficient clinical evidence – legacy vs new devices Post-Market Clinical Follow-Up (PMCF) support for MDR approvals Claims and clinical benefit…

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NAMSA Webinar: Assessing Sterilization Modalities to Meet Medical Device Requirements

May 20 @ 11:00 am - 12:00 pm
Webinar Online Event, OH United States

Join BioOhio member NAMSA on May 20 at 11am for the webinar Assessing Sterilization Modalities to Meet Medical Device Requirements. With much uncertainty surrounding Ethylene Oxide Sterilization, several medical device manufacturers are questioning the use of alternative sterilization modalities and trying to assess which modality might fit their product more suitably. Provided in this webinar will be an overview of the alternative modalities available and key criteria to consider during the selection process. Join NAMSA for this upcoming webinar to learn about: Alternative sterilization modalities and their…

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