FDA MedTech Regulatory Forum 2019

August 22 in Akron

The BioOhio FDA MedTech Regulatory Forum assembled Ohio’s most sought after leaders in the medical device industry, including FDA Investigators, experienced regulatory professionals, and innovative medical device professionals. We discussed current compliance standards, reviewed possible changes in new regulations, and explored trends within the industry.

This year’s agenda was packed with fascinating topics that boosted understanding of critical issues for medical device companies. See the full agenda and speaker bios below.

In partnership with

Location

Bounce Innovation Hub

526 S. Main St.

Akron, Ohio 44311

Agenda

8:00am – Registration, Networking, and Continental Breakfast

8:50am – Introductions, Opening Remarks

9:00am – A Case Study: Alignment of Quality Management Best Practices with Compliance

  • Moderated by Laura Green, President, Green & Associates, LLC
  • Allyson Capadona, QMS Consultant, Green & Associates
  • Jina Tweed, VP, Quality, PartsSource

9:45am – Current FDA Compliance Issues: FDA Panel Discussion & Q&A

  •  Moderated by Holly Lee, Sr Manager, Post-Market Surveillance, Philips Medical
  • Ben Dastoli, FDA Investigator
  • Laureen Geniusz, FDA Investigator
  • Laura Green, President, Green & Associates, LLC

11:00am – Break

11:20am – 510(k) Premarket Approval Process

  • Anthony M. Piotrkowski, RAC, CQA, Director, Regulatory Affairs, STERIS

11:55am – Marketing Claims and Clinical Support: Consumer Products & Med Devices

  •  Afif Ghannoum, CEO, BIOHM Health
  • Andrea Martter, MPH, RAC, Senior Regulatory Affairs Specialist, GOJO

12:30pm – Lunch

1:15pm – EU MDR Transition Progress

  • Holly Lee, Sr. Manager, Post-Market Surveillance, Philips Medical
  • Nancy Morrison, Executive Director of Regulatory & Quality Consulting Services, R&Q

2:00pm – Cybersecurity in Medical Devices

Cybersecurity Threat Landscape

  •  Dan Banick, Chief Information Security Officer, Warwick, Inc.

Medical Device Cybersecurity: Design and Risk Management Considerations

  •  Moderated by Dan Banick, Chief Information Security Officer, Warwick Inc.
  • Melissa Masters, President, CMD MedTech
  • Kevin Tambascio, Manager, Cybersecurity Medical Devices, Cleveland Clinic Foundation
  • Carla Wiese, Senior Product Development Strategist/Regulatory Consultant, NAMSA

3:00pm – Break

3:20pm – Medical Device Cybersecurity Compliance: Legal and Risk Elements Present and Future: Issues that Need Your Attention

  • Moderated by John Lewis, President & CEO, BioOhio
  • Walter Kawula, Partner, Hahn Loeser & Parks

4:10pm – Wrap Up, Closing Remarks, Forum Adjournment

4:00 – 6:00pm – Ohio Bioscience Networking Social in Akron at Missing Falls Brewery. 

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