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.

2019 Agenda Topics

FDA Inspector’s Panel Discussion

A Case Study: Alignment of Quality Management Best Practices with Compliance

  • Allyson Capadona, Director, Supply Chain Excellence, Invacare
  • Jina Tweed, VP, Quality, PartsSource

510(k) Premarket Approval Process

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

Marketing Claims and Clinical Support: Consumer Products and Medical Devices

Medical Device Cybersecurity: Design and Risk Management Considerations

  • Moderated by John F. Lewis, Jr., President & CEO, BioOhio
  • Melissa Masters, President, CMD MedTech
  • Carla Weise, Principal Medical Research Scientist, NAMSA

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

EU MDR Transition Progress

Clinical Data for EU MDR

In partnership with



Bounce Innovation Hub

526 S. Main St.

Akron, Ohio 44311



BioOhio Member: $175

Non-member: $275

BioOhio Student Member: $75

Previous FDA Regulatory Forums

Visit our Past Events section to see agendas from the 2014-2018 FDA Regulatory Forums

FDA Regulatory Forum 2014

FDA Regulatory Forum 2015

FDA Regulatory Forum 2016

FDA Regulatory Forum 2017

FDA Regulatory Forum 2018

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!