MedCon 2023 Agenda
Please note: Separate registration and fee are required to attend the workshop
APRIL 24, 2023 / WORKSHOP
7:00 a.M. – 5:00 P.M.
Registration
7:00 a.M. – 8:00 A.M.
Breakfast
Join your colleagues from around the globe as we kick off MedCon 2023 Workshop with a complimentary hot breakfast.
8:00 a.m. – 4:40 P.M.
Risk Management: Practical Applications of Risk Management Throughout the Device Life Cycle
Jump-start your deeper understanding of RMS regulatory authority expectations!
This workshop is meant for beginner to intermediate practitioners who want to go beyond the basic understanding of risk management system (RMS) requirements. The workshop will give a brief overview of the history of regulatory authority expectations related to risk management activities and delve into these practical topics with breakout group activities and discussions.
• Value of well-established risk assessment criteria
• Traceability tables from design specifications to IFUs to market applications
• Human Factors/Usability testing over the lifetime of your medical product
• Understanding the global regulatory authority sensitivity regarding “use errors”
• Pulling premarket risk data through to post-market data
• Correlating RMS data to post-market IMDRF Adverse Event Codes
• Product Risk Assessments for possible escalations to Field Safety Corrective Actions/Recalls decisions
Facilitators
Bill Brodbeck, Senior Director, Regulatory Affairs, STERIS
Shannon Hoste, Senior Director of Human Factors & Regulatory Strategy, Agilis Consulting Group
Tina Krenc, Principal Consultant, KTA Compliance Consulting
Brian Siroka, Associate Consultant, MEDIcept, Inc.
Kim Trautman, Managing Director and Vice President, MEDIcept Inc.
5:30 p.M. – 7:30 P.M.
Welcome Reception
Please join the MedCon Strategic Committee at the Hyatt Regency Columbus hotel for an evening welcome reception. Reconnect with colleagues and make new connections. Light hors d’oeuvres and beverages will be served.
APRIL 25, 2023 / DAY 1
7:30 a.M. – 5:05 P.M.
Registration
7:45 a.M. – 8:30 A.M.
Breakfast
Join your colleagues from around the globe as we kick off MedCon 2023 with a complimentary hot breakfast.
8:30 a.M. – 8:40 A.M.
Let’s Make a Difference!
Welcome to the conference, welcome back, and welcome to the Cincinnati District of the FDA. This purpose-driven conference will lead you to actionable learning and implementation plans!
Facilitator
Timothy Hsu, Chief Collaboration Officer, AFDO/RAPS Healthcare Products Collaborative
8:40 a.M. – 9:45 A.M.
Solutions Exchange
Start your day with solutions! This fast-paced, engaging session draws out your experience and ideas by having you work collaboratively with your colleagues to address the challenges that will be discussed throughout the conference, while tying your ideas to the hopes of a patient whose life is depending on you.
Facilitator
Fatemeh Razjouyan, Director of Regulatory Policy, International and Harmonization | Global Regulatory Policy, Medtronic
Shannon Hoste, President, Agilis Consulting Group
9:45 a.M. – 10:00 A.M.
Break
10:00 a.M. – 10:45 A.M.
Returning to the New Normal in the Face of Evolving Challenges: Update from CDRH Director, Jeff Shuren
Hear about CDRH’s strategic priorities, new initiatives, and ongoing work to return to the new normal in the wake of the COVID-19 Public Health Emergency. Jeff Shuren, CDRH Director, will provide his insight on several activities underway at CDRH to address the evolving challenges facing the medical device ecosystem, including the Medical Device User Fee Amendments (MDUFA V), the Total Product Life Cycle Advisory Program (TAP) pilot, medical device cybersecurity, the Digital Health landscape, and more. You won’t want to miss it!
Moderator
RADM Sean M. Boyd, Director, Office of Regulatory Programs, Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health (CDRH), FDA
Speaker
Jeffrey Shuren, Director of the Center for Devices and Radiological Health (CDRH), FDA
10:45 a.M. – 11:30 A.M.
Office of Regulatory Affairs (ORA) Office of Medical Device and Radiological Health Update
ORA’s Office of Medical Products and Radiological Health houses all medical device and radiological health investigators across the country. Elizabeth Miller, Associate Commissioner of the Office of Medical Products, will provide an update on the strategic priorities for medical products. Anne Reid, Program Director of the Office of Medical Devices and Radiological Health Operations (OMDRHO), will provide an update on OMDRHO’s key initiatives, strategic priorities, and inspectional and compliance activities.
Moderator
Gina Brackett, Division 1 Director, Compliance Branch, Office of Medical Device and Radiological Health Operations (OMDRHO), Office of Regulatory Affairs (ORA), FDA
Speakers
Elizabeth Miller, Assistant Commissioner of the Office of Medical Products and Tobacco Operations, Division 2, Office of Medical Device and Radiological Health Operations (OMDRHO), Office of Regulatory Affairs (ORA), FDA
Anne Reid, Program Director of the Office of Medical Devices and Radiological Health (OMDRHO), Office of Regulatory Affairs (ORA), FDA
11:30 a.M. – 12:30 P.M.
Networking Lunch
Day 1 – Midday Tracks (choose one):
12:30 P.M. – 2:00 P.M.
Medical Device User Fee Amendment (MDUFA) V: How Is It Impacting FDA Staff, Industry, and Patients?
Join this session to hear what was achieved with MDUFA IV, and learn about the MDUFA V commitments that are affecting FDA staff, the med tech industry, and patients. The session will cover the new TPLC Advisory Program (TAP), global harmonization efforts, premarket performance goals, and what’s expected of FDA in unlocking additional funding for FDA in FY2026 and FY2027.
Moderators
- Heather Rosecrans, Executive Vice President, Medical Devices & Combination Products, Greenleaf Health, Vice President Regulatory Affairs, MDMA
- Fatemeh Razjouyan, Director of Regulatory Policy, International and Harmonization / Global Regulatory Policy, Medtronic
12:30 P.M. – 2:00 P.M.
Are You Ensuring All Your Suppliers Are Meeting Purchasing Controls Requirements
Through interactive case studies with industry and FDA experts, gain a better understanding of actions you need to take to meet the Quality System Regulation to ensure that components and services conform to specified requirements.
Moderator
- Monica Wilkins, Vice President Regulatory and Quality, Abbott
Speakers
- Gina Brackett, Division 1 Director, Compliance Branch, Office of Medical Device and Radiological Health Operations (OMDRHO), Office of Regulatory Affairs (ORA), FDA
- Lauren Priest, Division 3, Compliance Officer, Office of Medical Device and Radiological Health Operations (OMDRHO), Office of Regulatory Affairs (ORA), FDA
- Monica Wilkins, Vice President Regulatory and Quality, Abbott
12:30 P.M. – 2:00 P.M.
The Effect and Impact of the MDR Delay – Controversies Continued
This session will take the form of a brief introduction to the latest regulatory changes in the EU MDR, followed by a moderated panel discussion. It will end with a Q&A session with the audience.
Moderators
- Kim Trautman, Managing Director and Vice President, MEDIcept Inc.
- Gert Bos, Executive Director & Partner, Qserve Group
Speakers
- Agata Anthony, VP Global RA and Regional QA, GE HealthCare
- Sabina Hoekstra-van den Bosch, Global Director Regulatory Strategy, TÜV SÜD Medical Health Services
- Glenda C. Marsh, Senior Director, EMEA, Regulatory Affairs Affairs, Johnson & Johnson
- Matthias Fink, Senior Clinical Consultant, Akra Team
2:00 p.M. – 2:15 p.M.
Break
Day 1 – Afternoon Tracks (choose one):
2:15 P.M. – 3:15 P.M.
Finding Common Ground: Managing Device Interoperability Expectations
This session will compare and contrast current global regulatory expectations for demonstrating medical device interoperability and the complexities manufacturers must overcome. Challenges associated with integrating internally developed devices with devices from other manufacturers will be discussed from the perspective of risk management, design verification, and human factors.
Moderator
- Francis Blacha, Senior Vice President, Quality, Eli Lilly and Company
Speakers
- Osman Kafrawy, Advisor, Device Quality and Regulatory Compliance, Eli Lilly and Company
2:15 P.M. – 3:15 P.M.
The Dos and Don’ts of 483 and Warning Letter Responses
Hear from FDA and industry on content expectations when writing a response to a Form FDA-483 Inspectional Observations or a Warning Letter.
Moderator
- Gina Brackett, Division 1 Director, Compliance Branch, Office of Medical Device and Radiological Health Operations (OMDRHO), Office of Regulatory Affairs (ORA), FDA
Speakers
- Monica Wilkins, Corporate Vice President, Regulatory and Quality, Abbott
- Melissa Michurski, Division 2 Director, Compliance Branch, Office of Medical Device and Radiological Health Operations (OMDRHO), FDA
- Gina Brackett, Division 1 Director, Compliance Branch, Office of Medical Device and Radiological Health Operations (OMDRHO), Office of Regulatory Affairs (ORA), FDA
2:15 P.M. – 3:15 P.M.
Security and Privacy
This session will broadly explore security and privacy as they impact medical device manufacturers and the healthcare delivery organizations using connected medical devices. The panel will discuss FDA’s cybersecurity guidance and collaborations, HIPAA, the FTC’s privacy enforcement activities, the E.U.’s General Data Protection Regulation (GDPR) and proposed European Health Data Space, and other elements of the evolving security and privacy landscape.
Moderator
- Eric Henry, Senior Quality & Regulatory Compliance Advisor, King & Spalding LLP
Speakers
- Igor Gorlach, Partner, Healthcare/Data, Privacy and Security, King & Spalding
- Jarno Vanto, Partner, Healthcare/Data, Privacy and Security, King & Spalding
3:15 p.M. – 3:35 p.M.
Break
Participants are invited to use this time to return to the plenary session held in the main conference room.
3:35 P.M. – 5:05 P.M.
Situation in UK & Switzerland
This session will take the form of a brief introduction on the latest regulatory changes in two European jurisdictions, followed by a moderated panel discussion and a final Q&A session with the audience.
Moderators
Kim Trautman, Managing Director and Vice President, MEDIcept Inc.
Gert Bos, Executive Director & Partner, Qserve Group
Speakers
Michael Maier, Vice President, Strategic Regulatory and Quality, Veranex
James Pink, Director, Medical, Element
5:45 P.M. – 8:30 P.M.
Annual MedCon Dinner (off-site)
Please join us at the Columbus Museum of Art, nestled in the heart of downtown Columbus! The evening will include dramatic architectural details, access to 10 galleries, and an unforgettable experience as the backdrop to your opportunity to dine and converse with your peers! Cocktails and dinner will be included! For more information on the Museum of Art, visit its website at https://www.columbusmuseum.org/.
Separate Ticket Purchase Required
APRIL 26, 2022 / DAY 2
7:30 A.M. – 5:15 P.m.
Registration Hours
7:45 A.M. – 8:30 a.m.
Breakfast
Join your colleagues from around the globe as we kick off the second day of MedCon 2023 with a complimentary hot breakfast.
8:30 a.m. – 8:35 a.m.
MedCon Day 2 Welcome
Moderator
Timothy Hsu, Chief Collaboration Officer, AFDO/RAPS Healthcare Products Collaborative
8:35 A.M. – 9:30 a.m.
Sustainability Throughout the Supply Chain: FDA and Industry Perspectives
Attendees will hear FDA and industry insights on the evolving supply chain landscape, including challenges and solutions through partnership. Speakers will address challenges we face as a community, such as planning for shortages and supply chain disruptions and mitigating adverse impacts.
Moderators
RADM Sean M. Boyd, Director, Office of Regulatory Programs, Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health (CDRH), FDA
Monica Wilkins, Vice President Regulatory and Quality, Abbott
Speakers
Tammy Beckham, Associate Director for Resilient Supply Chain, Center for Devices and Radiological Health (CDRH), FDA
Michael Hoffmann, Program Lead, Medical Device Shortages Program, Office of Product Evaluation and Quality’s (OPEQ) Shortages Team, Center for Devices and Radiological Health (CDRH), FDA
Meera Bhatia, Divisional Vice President, Quality, Abbott
Aaron Bernstein, Divisional Vice President, Procurement, Abbott
9:30 A.M. – 9:50 A.M.
Break
Day 2 – Morning Tracks (choose one):
9:50 A.m. – 11:00 a.M.
Biocompatibility – Where Are We Now?
Listen to FDA leaders discuss the most current expectations for medical device biocompatibility testing to be included in premarket submissions. Also hear updated trends and areas of concern from test lab experts as well as industry leaders’ experience with recent FDA submissions and preparation of technical files for EU Medical Device Regulation.
Moderator
- Bill Brodbeck, Senior Director, Regulatory Affairs, STERIS
Speakers
- Ed Margerrison, Director, Office of Science and Engineering, Center for Devices and Radiological Health (CDRH), FDA
- Kelly Coleman, Distinguished Toxicologist, Medtronic
- Thor Rollins, Senior Director of Toxicology and E&L Consulting, Nelson Labs, LLC
9:50 A.m. – 11:00 a.M.
The Essence of EU SSCP and EU PSUR
This session will discuss in panel style the best practices developed so far for sharing relevant clinical data in a transparent way in the new documents SSCP (Summary of Safety and Clinical Performance) and PSUR (Periodic Safety Update Report).
Moderator
- Gert Bos, Executive Director & Partner, Qserve Group
- Kim Trautman, Managing Director and Vice President, MEDIcept, Inc.
Speakers
- Sabina Hoekstra-van den Bosch, Global Director Regulatory Strategy, TÜV SÜD Medical Health Services
- Matthias Fink, Senior Clinical Consultant, Akra Team
9:50 A.m. – 11:00 a.M.
Uses of Real-World Evidence Including Patient Self-Reporting
Innovations in medical devices, including mobile apps, have resulted in novel data sources, including the device itself. Real-world evidence (RWE) and real-world data (RWD) are data relating to a patient’s health status and/or the delivery of healthcare routinely collected from a variety of sources. This session will discuss the current U.S. FDA regulatory approach for use of RWE in regulatory decision-making and describe the related FDA draft guidance. Additionally, the session will review current projects, which will provide insight into how RWD and RWE can play a role in supporting evaluation of the safety and effectiveness of drug and biological products.
Moderator
- Susan Matthias, CSO Special Assistant, Office of Medical Device and Radiological Health Operations (OMDRHO), Office of Regulatory Affairs (ORA), FDA
Speakers
- Daniel Caños, Office Director, Office of Clinical Evaluation and Analysis, Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health (CDRH), FDA
- Lindsay Bockstedt, Vice President, Global Health Economics and Outcomes Research, Medtronic
- Paul Coplan, Vice President and Global Head of Medical Device Epidemiology and Real-World Data Sciences, Johnson & Johnson
- Simon Mason, President of NESTcc, part of The Medical Device Innovation Consortium (MEDIC)
11:00 a.M. – 12:05 P.M.
Networking Lunch
Day 2 – Midday Tracks (choose one):
12:05 P.M. – 12:50 P.M.
As FDA Emergency Use Authorization (EUA) Phases Out, How Do You Transition to Legal Marketing — Or Not?
In December 2021, the FDA issued the draft guidance document entitled “Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.” This session will focus on where FDA is today with the status of EUAs and expectations for industry. Join FDA officials to hear how industry should be preparing and from industry experts on how they are preparing for continued marketing – or not. Also learn how FDA enforcement could come into play after the expiration of EUA.
Moderator
- Heather Rosecrans, Executive Vice President, Medical Devices & Combination Products, Greenleaf Health, Vice President Regulatory Affairs, MDMA
Speakers
- Eli Tomar, Associate Director for Guidance, Legislation and Special Projects, Office of Policy, Center for Devices and Radiological Health (CDRH), FDA
- Sue Dahlquist, Senior Director Global Strategic Regulatory & Clinical Affairs, Thermo Fisher Scientific
- April Veoukas, Director, Regulatory Affairs, Abbott
12:05 P.M. – 1:05 P.M.
Artificial Intelligence (AI)/ Machine Learning (ML): Path to the Future
This session will cover the current U.S. FDA regulatory approach for AI/ML-based medical devices and explore opportunities for further enhancement through evolving developments in regulatory science in the areas of predetermined change control plans, labeling for transparency, and avoiding unintended bias. Additionally, the session will touch on the intersection of U.S. regulatory frameworks and the evolving global regulatory landscape for these types of products.
Moderator
- Eric Henry, Senior Quality & Regulatory Compliance Advisor, King & Spalding LLP
Speakers
- Cassie Scherer, Senior Director of Digital Health Policy and Regulatory Strategy, Medtronic
- Troy Tazbaz, Director, Digital Health Center of Excellence, Center for Devices and Radiological Health (CDRH), FDA
- Scott Thiel, Corporate Head of Regulatory Affairs, Hologic
12:05 P.M. – 1:05 P.M.
Managing Medical Device Cybersecurity Risk in the Healthcare Ecosystem
The FDA’s April 2022 Draft Premarket cybersecurity guidance emphasized the importance of a Secure Product Development Life Cycle, including the essential role of communications to properly inform HDOs (Health Delivery Organizations) of key security characteristics. This session will explore essential elements of these communications in properly securing medical device deployment and operation throughout the healthcare ecosystem. This exploration will include highlighting the newly revised Joint Security Plan (JSP) from the Healthcare Sector Coordinating Council’s Cybersecurity Working Group. In addition, IMDRF best practice resources on SBOM (software bill of materials) and Legacy, along with other recently released resources, will be addressed. This presentation will also highlight the importance of transparency between MDMs (medical device manufacturers) and HDOs to ensure that medical device cybersecurity risk is adequately managed throughout the healthcare ecosystem.
Moderator
- Fatemeh Razjouyan, Director of Regulatory Policy, International and Harmonization | Global Regulatory Policy, Medtronic
Speakers
- Aftin Ross, Senior Special Advisor for Emerging Initiatives, Center for Devices and Radiological Health (CDRH), FDA
- Debra Bruemmer, Senior Manager, Mayo Clinic
- Chris Reed, Director, Regulatory Policy, Digital Health and Product Security, Medtronic
1:05 p.M. – 1:25 p.M.
Break
Participants are invited to use this time to return to the plenary session held in the main conference room.
1:25 P.M. – 2:10 P.M.
FDA Transition to ISO 13485/Update on Proposed Rule Aligning QSR With 13485 (QMSR)
FDA intends to harmonize and modernize the Quality System regulation for medical devices. The revisions will supplant the existing requirements with the specifications of an international consensus standard for medical device manufacture, ISO 13485:2016. Session participants will gain understanding of the status of the FDA’s proposed rule and implementation activities from FDA experts.
Moderator
Aaron Dunbar, Vice President QARA Compliance, Olympus
Speakers
Keisha Thomas, Associate Director for Compliance and Quality, Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health (CDRH), FDA
Karen Masley-Joseph, Senior Advisor, Office of Medical Device and Radiological Health Operations (OMDRHO), Office of Regulatory Affairs (ORA), FDA
2:10 P.M. – 3:10 P.M.
Global Regulatory Convergence and Shaping Innovation
Do you market your devices in more than one jurisdiction? Do you seek a predictable, risk- and capacity-based regulatory framework? The global medical device regulatory landscape continues to evolve and increase in complexity. It is crucial to prioritize regulatory convergence in support of efficient pathways for patient access to medical technologies with less cost. Join this session to hear the current state of global regulatory convergence efforts and initiatives and an update on International Medical Device Regulators Forum (IMDRF) efforts to further convergence. Lastly, this session will provide industry’s perspective on the importance of globally convergent regulatory requirements.
Moderator
Fatemeh Razjouyan, Director of Regulatory Policy, International and Harmonization / Global Regulatory Policy, Medtronic
Speakers
Erin Cutts, Senior International Policy Analyst, Center for Devices and Radiological Health (CDRH), FDA
Tammy Steuerwald, Global Regulatory Policy, Foundational Principles & Supranational Organizations, Roche
Augusto Bencke Geyer, Deputy General Manager of the Medical Devices Office, Brazilian Health Regulatory Agency (ANVISA)
3:10 p.M. – 3:30 p.M.
Break
3:30 P.M. – 4:15 P.M.
Innovating Submission of Premarket Applications – CDRH Portal and eSTAR Program
Listen to FDA Leadership describe novel technology solutions that facilitate the submission and tracking of your premarket applications. This session will cover CDRH’s electronic Submission Template AND Resource (eSTAR) program, which provides a dynamic, guided template for use in preparing premarket submissions and an update on the eSTAR Pilot announced in January 2023. Presenters will also share information on the CDRH Portal (Customer Collaboration Portal), which allows real-time tracking of 510(k) status for industry members. These system improvements have been hailed by industry as some of the most impactful CDRH has made for the device program, and will give participants valuable insight into each.
Moderator
Bill Brodbeck, Senior Director, Regulatory Affairs, STERIS
Speakers
Patrick Axtell, Assistant Director, Tools and Templates Team, Office of Regulatory Programs, Center for Devices and Radiological Health (CDRH), FDA
Nelson Anderson, CDRH Portal Platform Owner, Office of Regulatory Program, Center for Devices and Radiological Health (CDRH) FDA
4:15 P.M. – 5:15 P.M.
Demonstration of FDA Databases and Publicly Available Tools
This presentation will provide an overview and demonstration of FDA publicly available databases and tools that can be used to retrieve, download, and analyze FDA data, including Total Product Life Cycle Data, Recalls, Medical Device Reports, Inspections, 483 observations, Compliance, and other information. The speaker will also highlight CDRH’s educational tool, which includes learning modules covering both premarket and post-market topics and an introduction to CDRH’s Division of Industry and Consumer Education.
Moderator
Susan Matthias, CSO Special Assistant, Office of Medical Device and Radiological Health Operations (OMDRHO), Office of Regulatory Affairs (ORA), FDA
Speaker
James Hildreth, Division 2 Director, Investigations Branch, Office of Medical Device and Radiological Health Operations (OMDRHO), Office of Regulatory Affairs (ORA), FDA
5:30 PM – 7:30 PM
Networking Reception
After the conference sessions on Wednesday, benefit from open dialogue while enjoying drinks and hors d’oeuvres. You and your colleagues can continue to share ideas with Strategic Committee members and speakers in a pleasant, informal setting.
April 27, 2023 / DAY 3
7:30 A.M. – 12:00 P.M.
Registration
7:45 A.M. – 8:30 A.M.
Breakfast
Join your colleagues from around the globe as we begin the last day of MedCon 2023 with a complimentary hot breakfast.
8:30 A.M. – 8:35 A.M.
MedCon Day 3 Welcome
Moderator
Timothy Hsu, Timothy Hsu, Chief Collaboration Officer, AFDO/RAPS Healthcare Products Collaborative
8:35 A.M. – 10:30 A.M.
Investigator Insights
Every year at MedCon, investigators share insights on inspection trends they’ve observed. Hear from veteran FDA investigators with all three of the program’s divisions, who will “tell it like it is” from their perspective. Use this friendly forum to prepare today for tomorrow.
Moderator
Monica Wilkins, Vice President Regulatory and Quality, Abbott
Speakers
Edward Lockwood, Division 2 CSO, Office of Medical Device and Radiological Health Operations (OMDRHO), Office of Regulatory Affairs (ORA), FDA
Rafael Padilla, Division 2 Compliance Officer, Office of Medical Device and Radiological Health Operations (OMDRHO), Office of Regulatory Affairs (ORA), FDA
LCDR Thomas Peter, Division 1 Investigator/Medical Device Specialist, Office of Medical Device and Radiological Health Operations (OMDRHO), Office of Regulatory Affairs (ORA), FDA
Phil Pontikos, National Expert, Office of Medical Device and Radiological Health Operations (OMDRHO), Office of Regulatory Affairs (ORA), FDA
Janet Pulver, Medical Device Senior Operations Officer Division 3, Office of Medical Device and Radiological Health Operations (OMDRHO), Office of Regulatory Affairs (ORA), FDA
10:30 A.M. – 10:45 A.M.
Break
10:45 A.M. – 11:45 A.M.
Understand the Recalls Process from Initiation to Termination!
FDA will walk through the process of a recall (Correction and Removal) including the requirements of 21 CFR Part 806 and 21 CFR Part 7. This presentation will include what is often missing or needs further clarification to ensure that notification and processing are completed efficiently and patients are notified in a timely manner. Additional information will include what is needed to terminate your recall.
Moderator
Gina Brackett, Division 1 Director, Compliance Branch, Office of Medical Device and Radiological Health Operations (OMDRHO), Office of Regulatory Affairs (ORA), FDA
Speakers
Meredith Andress, Division 2 Recall Coordinator, Compliance Branch, Office of Medical Device and Radiological Health Operations (OMDRHO) Division, Office of Regulatory Affairs (ORA), FDA
Cynthia Aycock, Division 1 Recall Coordinator, Office of Medical Devices and Radiological Health Operations (OMDRHO), Office of Regulatory Affairs (ORA), FDA
11:45 A.M. – 11:55 A.M.
To Your Success!
Thank you for joining us, but we insist that you leave with action plans that will enable you to make a difference in your organization and for the patients you serve. Work with your colleagues on turning your learning into a full action plan!
Moderator
Timothy Hsu, Chief Collaboration Officer, AFDO/RAPS Healthcare Products Collaborative
Because of the generosity of our supporters, we can continue our work to improve the healthcare products industry.
Diamond Sponsor
Platinum Sponsor
Learn more about supporting MedCon 2024 through sponsorship by contacting Patrick Flynn at +1-301-770-2920, ext. 246, or pflynn@raps.org.
