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Regulatory and Quality Affairs: Answers to FDA and ISO Gray Areas

When: Wednesday, June 12 | 2:00 pm - 2:45 pm  
Where: Room 49 - Product Lifecycle Management TrackLevel: All
Participant Types: Research & Development, Product Development, Quality Control, Regulatory/Clinical Affairs

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Description

Every day, people like you in companies everywhere are sidetracked from more pressing priorities by questions and scenarios that aren’t clearly explained in a regulation or standard (a.k.a. "gray areas"). 

We’ve assembled a panel of regulatory and quality experts and charged them with mitigating your roadblocks and getting you on your way. Our panel will share their perspective on the pressing questions received from a pre-conference attendee questionnaire, including UDI and supplier relationships. Get your answers directly by attending this session.

Takeaways

  • Discover the FDA and ISO gray areas that challenge your peers...and receive the necessary guidance to optimally respond if you encounter the same scenario
  • Get insights into how regulatory and quality experts think through vague regulations and standards
  • Receive direct advice on your FDA and ISO roadblocks


Speakers 

Jeff Tyber, President, CEO and Founder of Tyber Medical, has worked in the orthopedic industry for over 12 years in product development, research and management roles.
Prior to founding Tyber Medical, Mr. Tyber was most recently the R&D Manager for Extremity Medical, where he and his product development group were responsible for the invention, development and release of 10+ products. Mr. Tyber previously served as a Design Engineer with B. Braun Aesculap in the spine division, and was a co-founder and Senior Engineer for MedShape Solutions. He is a named inventor on over 39 domestic and international patents and patent applications. Mr. Tyber graduated from the University of Colorado with an MS and BS in Mechanical Engineering.

Dawn Norman, Executive Vice President, MCR-X, has 20 years of experience in the medical device industry leading regulatory affairs, quality systems and clinical affairs in multiple start-ups and a major Fortune 500 company.
Ms. Norman's experience spans Class I, II and III medical devices, as well as combination and tissue product, such as recombinant proteins for bone fusion, spine, orthopedic trauma, software, imaging technologies, electrophysiology and interventional devices, vascular access and dental technologies. She holds a BA and MS from Southern Illinois University at Edwardsville.

Kimberly Light has worked in the medical device industry for over 20 years in roles ranging from product design and development to business development.
For the past four years, Ms. Light has served as the Director of Regulatory Affairs at BioPro. During her career, she has led multiple projects to design, implement and improve ISO 13485 compliant Quality Management Systems and processes and achieve and maintain regulatory compliance, including international licenses and product registrations. Ms. Light has been involved in multiple device development projects from conceptualization through global product registration, sales and marketing support and training on domestic and international levels. She holds a bachelor's degree in bioengineering from Syracuse University and a bachelor's in biology from S.U.N.Y Fredonia.

Ryan Belaney has worked in the medical device industry for more than 15 years in roles ranging from product development to regulatory and quality affairs.
Mr. Belaney currently serves as Senior Director of Regulatory Affairs at Active Implants. His previous positions including Director of Applied Research at RTI Surgical, Senior Director Regulatory Affairs and Quality Assurance at AgNovos Healthcare, Manager of Corporate Development and Senior Product Development Engineer at Wright Medical. He holds a Bachelor’s in Biology from the University of Mount Union and a Master’s in Biomedical Engineering from The University of Toledo.