Former FDA/CDRH Director to Speak at Regulatory & Quality Forum

June 12, 2017


Fresh from the FDA, John Sheets will talk Case for Quality, Real-World Evidence, and More

BioOhio, in partnership with R&Q, is once again teaming up with industry experts to bring you a program focused on regulatory issues pertinent to Ohio’s medical products industry.

This year’s event brings some of the medical device industry’s leading experts directly to you. We’ll discuss changing regulations and present actionable recommendations for next steps, along with examining other critical industry trends.

The event will facilitate great industry and professional networking in addition to the valuable content.

The Regulatory & Quality Forum is consistently one of our most popular and well attended events.


8:00 — Breakfast and Registration

8:30 — Welcome and Introduction

8:35 — Innovations at the FDA: Case for Quality, Real-World Evidence, and More

9:35 – Break

9:45 — ISO 13485:2016

11:00 — MDSAP

12:00 – Lunch  

1:00 — EU MDR

2:00 — MEDDEV 2.7/1 & CERs

3:00 — Drinks on R&Q! Discussion and Networking at Masthead Brewery


BioOhio Member (less than 11 employees): $150

BioOhio Member (11+ employees): $200

Non-member: $300

Student Member: $75

City and State Government: $150

Registration includes breakfast, lunch and 2 drink tickets at Masthead Brewery.

We hope to see you there, and please extend the invite to others!