FDA Regulatory and Quality Forum 2017
presented by R&Q

June 15th in Cleveland, Ohio

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 direct 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 Forum is consistently one of our most popular and well attended events.

This event is made possible by generous sponsorship of companies and organizations that value the power of partnerships and networking. Click here to learn more about sponsoring this event.


8:00 – 8:30 am: Breakfast and Registration

8:30: Welcome and R&Q Introduction

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

The Case for Quality has transformed into to a movement for quality beyond compliance. This important initiative between the FDA and medical device industry has moved past the metrics and competencies of quality professionals into maturity models and data analytics that will drive the value proposition of medical devices. Come and hear an update from industry professionals and what you can do in preparation for the next steps coming in this important industry collaboration.

  • John Sheets, Ph.D., Former FDA/CDRH Director, Office of Device Evaluation

9:35: Break

9:45: ISO 13485:2016

Outline of how organizations should establish a risk-based approach as outlined in the requirements of ISO 13485:2016, and the changes associated with implementation of the new edition of ISO 13485. Learn a basic understanding of the application of the risk-based approach in your QMS process, the evidence that will show this implementation to auditors, and how these are implemented in your update to your QMS.

  • Rem Siekmann, Principal Engineer, Regulatory and Quality Solutions (R&Q)

11:00: MDSAP

MDSAP can potentially offer a variety of important advantages. While currently optional for FDA, it will be mandatory for Health Canada in January of 2019. Times will be busy with limited qualified registrars, ISO 13485:2016 implementation by March 2019, and EU MDR by 2020. You will leave this session understanding MDSAP inside and out and be sufficiently prepared.

  • Jake O’Donnell, Former FDA, Senior FDA Compliance Principal, Regulatory and Quality Solutions (R&Q)

12:00 pm: Lunch

1:00: EU MDR (European Union Medical Device Regulation)

The upcoming EU MDR changes are significant, potentially impacting your device classification and the need for clinical data. Considering the overall timeline – including ISO 13485:2016 (March 2019) and MDSAP (if selling in Canada; Jan. 2019) – it will be difficult to get on notified bodies’ schedules. The time to plan and act on these changes is now. Your technical files, design dossiers, quality system documents, clinical plans, labeling (including UDI), software, and more will be affected. Plus new requirements are coming into play, including Eudamed and periodic safety update reports (PSURs). This session will describe what to do now, what to keep your eye on, and real-world examples that show how industry is working through the changes. Interpretations will evolve, but this session will absolutely help you navigate the process.

  • Mark Swanson, ISO Technical Committee 210 and Working Group 1 member, Director of Minnesota Operations, Regulatory and Quality Solutions (R&Q)

2:00: MEDDEV 2.7/1 Rev 4 & CERs

Be prepared for the new requirements of MEDDEV 2.7.1 Rev 4. The grace period offered by some notified bodies is ending and clinical evaluation reports (CERs) are being audited for compliance with the latest MEDDEV revision. Furthermore, the European Medical Devices Regulation (MDR) will impact CERs as well once the regulation comes into force. It is important to be proactive to ensure CERs will meet your notified body expectations. We will discuss the key changes and additional CER content required so that you can ensure your CERs are in compliance with MEDDEV Rev 4. Looking ahead to MDR enforcement, we will also discuss how the new regulations impact your CERs. Finally, we’ll look at the common mistakes manufacturers make and how to avoid them, suggestions from a Notified Body perspective, and case studies of the most common problems related to Rev 4.

  • Mark Swanson, ISO Technical Committee 210 and Working Group 1 member, Director of Minnesota Operations, Regulatory and Quality Solutions (R&Q)

3:00pm: Thought leader discussion and Q&A

The event will be followed by a networking reception at Masthead Brewery, conveniently located next-door to the forum venue.

In partnership with


Hosted by



Oswald Companies

1100 Superior Ave

Cleveland, OH 44114