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R&D Workshop: Navigating the Regulatory Landscape for Wearable Technology (WT)
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6/7/2017
When: Wednesday, June 7, 2017
7:30am Breakfast & Registration; 8-9:30am Program
Where: NITA Training Center
1685 38th Street
Suite 200
Boulder, Colorado  80301
United States
Contact: Tracey Nilson
303-592-4088


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Overview:
Wearable Technology (WT) is on the rise, with sales expected to reach upwards of 100 Billion USD by 2018.   Wearable Medical Technology supports users with self-management of disease and chronic conditions and provides caregiver teams access to data which  can improve coordination of healthcare delivery for  the user. 

UL helps manufacturers understand and meet the complex regulatory landscape for medical wearable technology.

This program will provide an overview of the following topics as they relate to Wearable Technology:
Quality management and safety requirements
Performance verification
Interoperability
Data security 
Non-clinical testing to assure products safeguard against bodily harm.

Course Fee: $45 (non refundable but transferable within company)

Speakers Bio:
Justin Heyl, Solutions Business Development Director for UL  
Justin is responsible for the management of UL LLC’s suite of services to support regulatory approvals for medical device companies in NA, a member of the Health Sciences Global Leadership Council and the Global Sales Council for UL. He joined UL as the Global Account Director supporting Boston Scientific, Medtronic, St. Jude and supporting the global accounts team with medical related compliance services. Prior to joining UL, he was the program manager for Intertek’ s consulting services, worked as an orthopedic sales representative for Primary Surgical and a mechanical engineer for Crane Engineering and Forensic Services. He has partnered with medical device companies throughout the product development cycle and certification to expedite market access on a global scale. He has successfully managed projects with small start-up and VC backed companies, as well as many of the top 10 medical companies in the world.  Justin holds a Bachelor of Science degree in Mechanical Engineering from the University of Minnesota and has over twenty-one years of industry experience focusing on medical regulatory solutions and business development with medical companies.

 

Program partner: Design Solutions, Inc.

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