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Date/Time
Date(s) - 01/23/2018
12:30 pm - 6:00 pm EST

Location
Hilton Garden Inn Boston/Waltham

Categories

NAMSA’s IVD Summit program brings thought leadership and medical device professionals directly to you! This complimentary, half day event provides expert discussions through presentations, panel conversations and experiential learning. Attendees leave equipped with best practices, proven strategies and resources required for successful IVD product development and market introduction.

Discussion points will include:

  • Regulatory Updates & Guidance (MDR, IVDR)
  • IVD Clinical Trial Recommendations
  • Quality Systems Overview (ISO)
  • Global Regulatory Submission Pathways
  • Real-World IVD Case Studies

Please join us on January 23, 2018, at the Hilton Garden Inn (Waltham, Mass.) for this unique event! Summit registration will begin at 12:30 p.m. (EST), and a networking reception with light appetizers/drinks will follow at 5:00 p.m. EST.

 

AGENDA

Global Regulatory Pathways: Planning for Successful Submissions
Learn how to avoid common regulatory mistakes and helpful tips of the trade for international IVD submissions. Discussion will also include how to master the market clearance process without becoming victim to common pitfalls.

Clinical Research: Finding the Right Balance of Speed & Expertise

Clinical research is a critical component of medical device development occurring throughout the entire IVD product development continuum. Learn what types of clinical research can help best guide IVD product designs, and how different types of clinical evidence may be able to support market penetration and market expansion. Also discussed will be how manufacturers can realize true time and cost efficiencies by collaborating with the right development partners for clinical studies.

NAMSA’s IVD Expertise

Getting your IVD innovation to market…faster.

NAMSA is a leading contract research organization (CRO) and the world’s only Medical Research Organization (MRO) that assists In Vitro Diagnostics (IVD) manufacturers translate great ideas into great medical products.

From point-of-care diagnostics to instrument platforms to companion and complimentary devices, NAMSA provides global expertise for the full product development continuum. Through our regulatory consulting, laboratory testing and clinical research services, we consistently deliver proven time savings and cost efficiencies to clients around the world, resulting in hundreds of successful IVD submissions.

NAMSA also specializes in the design and conduct of IVD clinical trials by creating smaller, focused teams of IVD experts who customize data collection methods and monitoring plans to appropriately meet site, instrumentation and logistical requirements of each study. With over two dozen statisticians on staff, many of whom previously worked for the U.S. Food & Drug Administration (FDA), our biostatistics teams possess the knowledge to effectively model IVD studies and perform associated analyses to help manufacturers speedily and successfully introduce innovative products to the marketplace.

Learn more about our IVD expertise here.

Event Details

Attendee 1