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RAPS Florida: IVDR Breakfast
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RAPS Florida: IVDR Breakfast

When: May 17, 2019
Where: Beckman Coulter
11800 SW 147th Ave Bldg 4
Miami, Florida  33196
United States

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Come engage with others from your local regulatory community over breakfast and participate in two interactive presentations; the first on valuable communications skills helpful to anyone, regardless of specialty and the second on complying with the new EU regulations. The program will begin by examining communication methods that help hold your audience’s attention, whether it is a one-on-one meeting or a presentation to a group. We’ll then switch topics and dive into key challenges to be aware regarding the new EU regulation on in-vitro diagnostic medical devices (IVDR) that came into effect in May 2017.

Whether you’re with a medical device manufacturer or in another industry altogether, there will be something for everyone at this breakfast meeting!

Topic One: The New IVDR – Key Information in a Nutshell
Since the new EU Regulation on IVDR came into effect in May 2017, the clock is ticking for all parties involved in the manufacturing of in-vitro diagnostics (IVD). The new regulation introduces more stringent clinical and post-market surveillance requirements for medical device manufacturers, regardless of risk classification. Come join us to learn strategies that can help your orthopedic device company navigate the higher level of scrutiny, including:

• General comparison: IVDD vs. IVDR – key changes
• IVD product classification
• Annexes II & III – comprehensive Technical Documentation requirements
• Timeline and impacts to manufacturers and EU market access
• IVDR readiness considerations for Notified Bodies and manufacturers

Topic Two: How to Fully Engage an Audience through Active Listening

Even the most experienced presenters often miss what is essential to their audience. This presentation will illuminate how to engage and hold your audience’s attention by teaching you how to communicate what the audience really needs and wants to hear and to develop active listening skills. Attendees will learn:

• How to analyze your audience and know what they need
• How to engage your audience – starting with knowing your material 
• How to get rid of distractions and be in the “here and now”
• How to ask questions and hear what your audience is really saying

This event is coordinated by the RAPS Florida chapter and is intended to encourage knowledge sharing and community development. Continental breakfast will be provided, compliments of Regulatory Compliance Associates, Inc., and RAC holders may claim three RAC recertification credits.

Featured speaker:
Dr. Vivian Ngan-Winward, PhD, medical device product specialist and lead auditor, TÜV SÜD America
Jerry Michaels, MS, communications consultant, strategist, 3D Communications

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