FDA MedTech Regulatory Forum

August 22 in Akron

In 2019 BioOhio will once again team up with industry experts to bring you a program focused on regulatory issues pertinent to Ohio’s medical device industry. 

The FDA Regulatory Forum consistently assembles some of the medical device industry’s most experienced regulatory professionals. We will discuss changing regulations and present actionable recommendations for next steps, along with examining other critical industry trends. 

This event is made possible by generous sponsorship of companies and organizations that value the power of partnerships and networking.

In partnership with

Location

Bounce Innovation Hub

526 S. Main St.

Akron, Ohio 44311

Rates

BioOhio Member: $175

Non-member: $275

BioOhio Student Member: $75

Agenda

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

8:50am – Introductions, Opening Remarks

8:50am – A Case Study: Alignment of Quality Management Best Practices with Compliance

  • Moderated by Laura Green, President, Green & Associates, LLC
  • Allyson Capadona, Director, Supply Chain Excellence, Invacare
  • 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, Cincinnati District
  • Laureen Geniusz, FDA Investigator, Cincinnati District
  • Laura Green, President, Green & Associates, LLC

11:00am – Break

11:20am – 501(K) Premarket Approval Process

  • Anthony M. Piotrkowski, RAC, CQA, Directory, Regulatory, STERIS

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

  •  Afif Ghannoum, CEO, BIOHM Health

12:30pm – Lunch

1:15pm – EU MDR Transition Progress

  • Moderated by Nancy Morrision, Executive Director of Regulatory & Quality Consulting Services, R&Q
  • Holly Lee, Sr. Manager, Post-Market Surveillance, Philips Medical
  • Notified Body (TBA)

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 Clinical Foundation
  • Carla Weise, Principal Medical Research Scientist, NAMSA

3:00pm – Break

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

  •  Moderated by Thomas Washbush, Partner, Washbush Business Law
  • Walter Kawula, Partner, Hahn Loeser
  • Sagar Patel, Lead Medical Security Engineer, Medical Devices and Health Analytics, Battelle

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

4:00 – 6:00pm – Ohio Bioscience Networking Social in Akron, free to attend. Details to be announced.

Regulatory Forum Sponsorship Opportunities

The Regulatory Forum is a consistently popular event among BioOhio’s community. Regulatory Forum sponsorship is available for $1,500.

If you wish to combine your annual BioOhio membership and event sponsorship, we will reduce your annual dues by $200.

Sponsorship benefits include:

  • Table/exhibit space located in the pre-function area, and among all-day beverage station, breakfast, lunch buffet, reception.
  • Company logo/hyperlink on all event promotional material (BioOhio website, e-blasts)
  • Text acknowledgement of support on twitter and BioOhio LinkedIn Group
  • Logo exposure throughout event
  • Organization description and logo in the event booklet
  • Registration list (pre-event)
  • Attendee list with contact information (post-event)
  • Company representative name badges tagged as “Sponsor” at event
  • 1 complimentary event registration

First-time event sponsors will receive a 10% discount. 

Contact Jen Goldsberry by email or (614) 675-3686 for more information and sign up today!