MEDICAL DEVICES

Expand your scope and knowledge of the medical devices field. Our sessions will explore global trends in both emerging and developed markets, agency guidance changes and other topics that impact the regulatory professional throughout the product lifecycle including clinical, quality and compliance.

MONDAY, 11 SEPTEMBER
8:30­­–10:00 am

Medical Device Single Audit Program (MDSAP)

IMDRF has begun developing a standard set of requirements for auditing organizations performing regulatory audits of medical device manufacturers’ quality management systems. The standard will be applicable to competent authority auditing groups/inspectorates, as well as third party organizations that conduct such audits. The MDSAP Work Group has completed its work and has moved to the implementation phase. The MDSAP audit is, in fact, quite different than that of an ISO 13485 or Notified Body audit. Join us to learn about the experiences of auditing organizations and manufacturers on their pre-audit planning activities, auditing approaches and post-audit activities. Plus, hear about factors necessary for the long-term success of the program from all stakeholders involved.


Hiromi Kumada, assessor, Division of Registered Certification Body Assessment, Office of Manufacturing, Quality and Compliance, PMDA
Patricia Murphy, global head, MDSAP Program, BSI
Nancy Shadeed, special advisor, International Programs Division, Health Canada
Kim Trautman, MS, executive vice president, medical device international services, NSF International


US FDA Regulation Changes: Clinical Evaluation: Obtaining Full FDA Approval of an IDE

Obtaining full FDA approval of an investigational device exemption (IDE) is a critical step in the process of obtaining practical clinical experience and gathering valuable clinical evidence with your medical device. During the presentation, the FDA will share their perspectives on the pitfalls and opportunities associated with preparing an IDE submission and interacting with FDA before, during and after the submission. The goal is to convey important observations and recommendations that will help you to understand how FDA reviews IDE submissions and how to prepare a submission that “tells your story” while fulfilling all of the applicable regulatory requirements and providing all of the technical details. Ultimately, FDA would like to make the IDE submission and review process as efficient as possible for everyone involved, both for sponsors and for FDA review staff. This presentation will also include the perspectives of an experienced sponsor/CRO, to help you understand how to apply what you learn.


Richard Kotz, senior medical research scientist, NAMSA
Jennifer Mischke, MPH, director of biostatistics and data management, NAMSA
Ken Skodacek, policy analyst, Clinical Trials Program and Payer Communication Task Force, CDRH/FDA
Andreas Wiegand, RAC, director, US affairs, Siemens Healthcare Diagnostics


Reprocessing of Medical Devices in the Light of the EU MDR

Everybody is focusing on the compliance of the higher risk devices, but what about surgical instruments along your high-risk device that are to be reprocessed by Central Sterile Supply Departments (CSSD) in hospitals? What about your Single Use Devices (SUD) that may be reprocessed under the conditions defined in the MDR? The awareness about these aspects of the new European MDR is not yet sufficiently present among manufacturers and it is time for RA professionals to make a wakeup call. In this session, you will get the answers to your questions related to reprocessing of surgical instruments and SUD in Europe’s new regulatory environment.


Bill Enos, global head of microbiology, medical devices, BSI Healthcare
Michael Maier, senior partner, Medidee Services SA


10:30 am–12:00 pm

ISO 13485:2016

The revised ISO 13485:2016 is the international standard that defines quality management system requirements for organizations that are or may become involved in one or more stages of the medical device product lifecycle. ISO 13485:2016 certifications can now officially also be issued to suppliers or external parties that provide product and quality management system-related services to such organizations. Join us to learn key changes in this standard’s scope, other important changes that might not have been noticed, suggestions on how to perform the necessary gap analysis, and how to prepare for the transition deadline of 1 March 2019.

Brian Ludovico, executive director, MDSAP regulatory certification, NSF Health Sciences
Patricia Murphy, global head, MDSAP Program, BSI
Kim Trautman, MS, executive vice president, medical device international services, NSF International


Recalls/Corrections/Removals

Protecting a patient’s health is everyone’s job and despite the impact of technology on manufacturing processes, recalls and corrections remain a daily fact of life. How we conduct recalls and corrections can determine the fate and success of both companies and careers alike so it is essential that our industry put its best foot forward in these demanding situations. In this session representatives from FDA and industry will discuss a broad array of topics and be able to ask questions which can help guide our approach to field actions, what strategies works best, how to communicate with FDA, hospitals and patients and how to react to public inquiries. Learn what to if your firm has a Class I recall, common mistakes companies make when recalling products, the best ways to communicate with FDA headquarters, points to include in an effective notification letter, and so much more. 

Rita Hoffman, RAC, principal consultant, Regs & Recall Strategies LLC
Robin Newman, MSN, EdD, director, Office of Compliance, CDRH/FDA
Frank Pokrop, director, quality and regulatory affairs, BD  


Human Factors Studies/Usability Engineering

Join us to get an understanding of the usability engineering process as set forth in IEC 62366-1 and 62366-2 and how it differs from IEC 62366:2007. We will discuss ways to implement the process effectively, referencing a variety of real life examples of approaches that worked and didn't work. This presentation will also discuss the differences between IEC 62366:2007 and IEC 62366-1:2015 and the role of IEC 62366-2. Get a review of real life case studies of various medical devices, plus hear successes and lessons learned, so you can apply tips for practical implementation to your own device projects.


Xin Feng, PhD, human factors reviewer, human factors pre-market evaluation team, CDRH, FDA
Kim Konston, PhD, Biomedical Research Fellow, Division of Biomedical Physics, OSEL, CDRH, FDA
Bob Marshall, chief editor, Med Device Online
Theresa Miles, director of client solutions, Regulatory and Quality Solutions LLC (R&Q)
Pooja Roychoudhury, MS, MBA, principal engineer, Regulatory and Quality Solutions LLC


1:15–2:45 pm

EU MDR and IVDR: Overview

With the publication of the new EU medical device and IVD regulations, are you prepared to meet the required 2020 compliances? Start planning now by attending this session. Learn the major changes between the Medical Device Directive and regulations, including differences between the proposed and final text. We will highlight timelines for implementation. Find out the Notified Body expectations of manufacturers, expected challenges, timelines, readiness to audit, and impact of Brexit on the CE marking process. Hear industry perspectives on the planning process and unexpected challenges during the transition process. Plus, we’ll discuss the impact on legacy directive products and re-accreditation of legacy product based on postmarket data.


Roshana Ahmed, associate director, regulatory affairs, medical devices, Mapi Group
Philippe Auclair, PharmD, PhD, FRAPS, senior director, quality and regulatory, EMEA, Abbott Laboratories Inc.
Gert Bos, PhD, FRAPS, executive director and partner, Qserve Group
Tina Lochner, MS, MBA, president, MEDCERT-USA, LLC


Regulatory Strategy and Rapid Technology Innovation: From Additive to Algorithm

A tide of innovations in additive manufacturing, artificial intelligence and deep learning and other technological advancements is becoming increasingly relevant for regulatory professionals, and these advancements are fundamental to the next decade of science and medicine. Rapid innovation, however, poses a challenge to both policy makers and professionally tasked with navigating complex and dynamic technology clinical and regulatory landscapes. This session will examine the state of recent FDA and industry guidance, as well as regulatory pathways for both 3D printed additive devices and the software components integral to their function. Join us to learn how to achieve fluency in additive manufacturing and software component discourse, for more effective strategy discussions and interactions with regulatory agencies.


Robin Fitzgerald Martin, MBA, RAC, co-founder and chief regulatory strategist, Kinetic Compliance Solutions LLC
Angela Johnson, PMP, RAC, clinical writer, GE Healthcare


Global Regulation Changes: India
The Indian government has recently introduced a significant overhaul of its system for regulating medical devices and IVDs. Compliance is approaching quickly in January 2018. You can expect more formalized registration requirements for the devices that are currently registered. Additionally, risk-based classification is a new approach in this geography, as well as manufacturing audits we have not seen in the past. How ready is your business? Join our panel of experts in providing a detailed description of what you can expect and how to best take advantage of the transition period in order to comply with the new regulations following the 2018 implementation.

Mukesh Kumar, PhD, RAC, adjunct assistant professor, clinical research and leadership, George Washington University
Amra Racic, MBA
, principal regulatory affairs policy and advocacy specialist, Medtronic
Sumati Randeo, director global strategy regulatory affairs and advocacy, Abbott

4:00–5:30 pm

EU MDR: Clinical Evaluation/Classification

The requirements, including the extent of clinical evidence needed, for the European Union’s Clinical Evaluation is continually evolving. With the release of Revision 4 of the MEDDEV 2.7/1 guidance entitled “Clinical Evaluation: A Guide for Manufacturers and Notified Bodies Under Directives 93/42/EEC and 90/385/EEC,” as well as the new medical device regulations (MDR), it is critical that manufacturers understand and address requirements to facilitate rapid market access to countries relying on the CE mark. Key takeaways from this session include strategies for literature evaluation, scoping “the right” research questions and perspectives on leveraging data from equivalent competitive products. Upcoming requirements from the MDR will also be considered.


Bassil Akra, PhD, director, Clinical Centre of Excellence, TÜV SÜD Product Service GmbH
Carine Cochereau, PhD, QRA and clinical director EMEA, Cardinal Health 
Robin Fitzgerald Martin, MBA, RAC, co-founder and chief regulatory strategist, Kinetic Compliance Solutions LLC
Keith Morel, PhD, vice president, regulatory compliance, Qserve Group US Inc.


Medical Device Innovation Consortium (MDIC) Including the National Evaluation System for Health Technology (NEST)

The US Food and Drug Administration (FDA) has awarded the Medical Device Innovation Consortium (MDIC) $3 million in seed funding to establish the Coordinating Center for the Medical Device National Evaluation System for health Technology (NEST). Simultaneously, the establishment of NEST is moving the industry towards greater utilization of real-world data (RWD) sources. As NEST seeks to leverage and aggregate practice data from various real-world data sources including clinical registries, electronic health records and medical billing systems to enable patients and providers to make better data-driven treatment decisions, the industry is faced with many questions. Join the FDA and other leading experts as they discuss how this collaboration could affect the medical device industry and what changes we can expect as a result of this new effort.


Paul Brooks, executive director, RAPS
Rachael Fleurence, PhD, executive director, National Evaluation System for health Technology Coordinating Center (NESTcc)
Michelle McMurry-Heath, vice president regulatory affairs, Johnson & Johnson
Bill Murray, president and CEO, MDIC
Greg Pappas, MD, PhD, associate director, National Device Surveillance, Center for Devices and Radiological Health, FDA
Pat Shrader, vice president, global regulatory affairs, Medtronic


Global Regulation Changes: Latin America

Medical devices are essential for the prevention, diagnosis, treatment and rehabilitation of diseases. In the last decades, these products have acquired great relevance across the healthcare sector with associated economic repercussion on a worldwide basis, also becoming relevant to the future of medicine. The national regulatory authorities (NRA) across the Latin American region are responsible for the safety, effectiveness and quality of medical devices, implementing effective and timely controlled regulatory systems in order to guarantee patient access to safe health technologies. Join us to gain insights of the national experiences and regional initiatives across Latin America presented by the key NRAs, in an effort to help strengthen the regulation of medical devices across the Americas. These initiatives have been spearheaded, supported and coordinated in recent years by the PAHO/WHO Collaborating Center for Health Technology Regulation of the CECMED (Cuban National Regulatory Agency) at a regional level.

Jarbas Barbosa da Silva Jr., president, National Agency of Health Surveillance, Brazil
Silvia Bendiner, director business development and regulatory affairs-Latin America, Mapi Group
José Coto, MD, head, Ministry of Health, El Salvador
Javier Guzmán Cruz, director general, National Food and Drug Surveillance Institute, Colombia
Rafael Perez Cristiá, head, National Regulatory Agency, Cuba 


TUESDAY, 12 SEPTEMBER
8:30­­–10:00 am

US FDA Regulation Changes: When to Submit a 510(k) for a Change to an Existing Device

In August 2016, FDA released two draft guidance documents for manufacturers on when changes to a device or software would require a change to be made to a 510(k) submission. The update from 1997 guidance further clarifies when device makers are required to submit a 510(k) when a change could significantly affect the safety or effectiveness of the device. This session will dissect the difference between the current and newly proposed draft guidance, provide clarification provided by this guidance, and show how risk management is utilized to determine when change requires a 510(k).

Steven Binion, PhD, MBA, senior director, corporate regulatory policy, BD
Michael Ryan, regulatory advisor, ODE, CDRH/FDA
Marjorie Shulman, MBA, chief of premarket notification 510(k) section, ODE, CDRH, FDA
April Veoukas, director of regulatory affairs, Abbott Quality & Regulatory


10:30 am–12:00 pm

EU MDR and IVDR: Postmarket Expectations Including PMCF

This session will explore the upcoming changes resulting from the new EU MDR with respect to preclinical and postmarket surveillance, including postmarket clinical follow-up and continuous reporting of the postmarket clinical follow-up activities via Postmarket Clinical Follow-up Reports (PMCFR). You will benefit from an overview of the requirements as well as the insight from a Notified Body, a manufacturer and a CRO’s perspective.


Mindy McCann, MS ChE, vice president, regulatory compliance US, Qserve Group
Florianne Torset-Bonfillou, director, regulatory, education and quality, LNE/G-MED North America Inc.
Michael Maier, senior partner, Medidee Services SA
David Rutledge, director, Abbott Vascular


Medical Device Harmonization Initiatives

Regulatory harmonization, cooperation and systems strengthening are the focus of global and regional initiatives involving regulators, the World Health Organization, and other stakeholders in the regulation of medical devices. These initiatives align regulatory requirements and advance public health through collaboration and mechanisms including adoption of technical guidance and standards and common practices and procedures. Join us to receive an overview from industry on current harmonization initiatives, the relationships between initiatives, and common work areas. Plus, gain information and insight from representatives of IMDRF, AHWP, and PAHO on the following topics:  key work items, the best approach for monitoring the work of these organizations and how to become more involved as a stakeholder.   


Philippe Auclair, PharmD, PhD, FRAPS, senior director, quality and regulatory, EMEA, Abbott Laboratories Inc.
Alexandre Lemgruber, regional advisor, health technologies, PAHO/WHO
Marcela Saad, MSc, PharmD, RAC (Global), FRAPS, president and senior consultant, MarcM Consulting Canada
Diana Salditt, FRAPS, regulatory advocacy program director, Medtronic
Nancy Shadeed, special advisor, International Programs Division, Health Canada


How to Prioritize Your CAPA Activities

When auditors and investigators uncover deficiencies in medical device manufacturers’ quality systems, the challenge is to take corrective action in a timely manner. Distinguishing between corrective actions that are urgent, important or nonessential is problematic. In a high-energy, interactive session, attendees will discuss best practices for prioritizing their remedial activities for quality system deficiencies, including those for legacy products and processes. They will have the opportunity to compare their answers with former and current FDA officials and industry experts.


Captain Sean Boyd, deputy director of regulatory affairs, OC, CDRH, FDA
Denise Dion, vice president regulatory and quality services, Eduquest
Nancy Singer, JD, LLM, RAC, FRAPS, president, Compliance-Alliance


1:15–2:45 pm

EU Medical Device Regulation (MDR): Which Issues Are Still Open?

Industry can expect many milestones between now and May 2020, when the new European medical devices regulation becomes enforced. A new and complex regulation is now published, but several sub-regulations are in the pipeline, along with guidance documents, common specifications, new standards, harmonized electronic forms, and a new European databank on medical devices (EUDAMED). Attend this session to better understand how, when and why these milestones will enable, or endanger, your compliance plans.

 

Daniel Moelands, PharmD, MBA, senior director, global regulatory and operations, Medtronic


The Art of Getting CFDA Premarket Approval in the Shortest Time Possible

China is the 2nd largest medical device market in the world with double digit growth. This session will cover how CFDA medical device and IVD regulatory changes affect the registration process and the best practice to cope with the regulations. Clinical evaluation and clinical trial changes will be covered as well. Seasoned experts will identify common mistakes made and provide constructive strategies to reduce registration time and cost, plus shorten time to market for medical device and IVD.


Grace Fu Palma, CEO, China Med Device, LLC
Danielle Giroud, MBA, CEO, MD-CLINICALS SA
Xiaoyun (Linda) He, manager, global strategy, China regulatory affairs, DePuy Synthes
Qianqian Zhu, MBA, LLM, RAC, international regulatory affairs manager, Immucor Inc.


Regulatory Strategies and Techniques for Faster Market Access

By using advanced methods and tools, leading regulatory affairs professionals are managing multiple product registration processes in many countries in real-time, more effectively than ever. This session will outline the importance of building global requirements into the design of the device from concept phase and to engage regulatory affairs, senior management and other departments from the very beginning of the development. You will learn how to deal with the changing global regulations, communicating them to key stakeholders within your company and how to develop a successful regulatory strategy that can make your company successful globally. Get a demonstration on how to execute regulatory strategies in any market, independent of third parties, using the most advanced product registration technology available to the medical technology industry. Find out how the use of technology can align business and regulatory strategies towards generating growth while expediting time-to-market and significantly cutting regulatory costs.


Maham Ansari, MS, RAC, director of regulatory affairs, Synaptive Medical
Benjamin Arazy, founder and CEO, Arazy Group Consultants Inc.


4:00–5:30 pm

EU MDR and IVDR: International Impact of the New EU Regulations

The impact of the new EU regulations will be felt globally, beyond the immediate effect on device access in the EU. You will hear from the experts from Med Tech Europe, the EU Commission, MHRA and other key opinion leaders about the international challenges and opportunities that they foresee. We are offering you a great in-depth discussion around emerging market registrations and tenders, the EU’s coordination efforts with other international regulators and partners, and the potential Brexit impact on the regulatory community. This course will help tie it all together.

 

Daniel Moelands, PharmD, MBA, senior director, global regulatory and operations, Medtronic
Jesús Rueda Rodríguez, director international affairs, MedTech Europe
John Wilkinson, MBA, director of devices, Medicines and Healthcare products Regulatory Agency


Software as a Medical Device

With technology moving at a rapid pace, significant growth in medical device has been the role of software from standalone devices to mobile apps. This fast-paced creation of software products may be placing users and patients at risk due to a lack of regulatory clarity from authorities. This session will provide clarity on what regulations actually apply and if your software product qualifies as a medical device.

  

Steven Binion, PhD, MBA, senior director, corporate regulatory policy, BD  
Michelle Jump, MS, MSRS, RAC, principal regulatory affairs specialist, Stryker
Bakul Patel, associate center director for digital health, CDRH/FDA


Global Regulation Changes: China


Regulations for the Supervision and Administration of Medical Devices, formally known as Order 650, is now referred to Order 680. How much has changed in the latest overhaul of China’s system for regulating medical devices and IVDs, and how does this affect your business? Are you up to date with the Green Channel opportunities in China? Have the Clinical Evidence Reports become more defined? In our session, learn best strategies in the fast moving regulatory environment in China and assure that you are prepared with your new generation of devices entering that market.

Kerry George, clinical study manager, Medtronic
Seth Goldenberg, PhD, director, product development strategy, NAMSA
Amra Racic, MBA, principal regulatory affairs policy and advocacy specialist, Medtronic
Yuanyuan Yu, regulatory affairs, Sciex