Quality & Regulation Track
Moderator: Marina Lebel, VP Medical Device, Gsap
VP, Medical Device
11:20 - 11:40
The Challenges of 2023 in Quality and Regulation Management in Medical Devices
The lecture will deal with the challenges that the quality and regulation department has to face, in order to meet the growing and changing regulatory requirements, as well as the management of the interfaces with the various departments in the organization (such as development, operations and marketing) and will suggest an organizational structure that can allow an effective and efficient management of quality and regulation in the company.
The lecture will cover various markets: Europe (MDR, IVDR, Great Britain, Switzerland), USA (CFR), MDSAP countries (Canada, USA, Australia, Brazil and Japan) and Israel (AMR).
QA&RA specialist, consultant and Lecturer, with vast experience in establishing and managing QA&RA systems. Leading the medical device section in Gsap for 7 years
11:40 - 12:00
Understanding and Taking Advantage of the Changing Regulatory Environment For Digital Health Products in Europe
The attendees will learn about key developments affecting the marketing of digital health products in the EU and the UK and how to make best use of this changing environment (e.g. new transitional provisions of the EU MDR, the IVDR, the UKCA marking requirements, European Health Data Space, AI act)
As partner of our Life Sciences practice, Fabien Roy focuses his practice at Hogan Lovells on advising clients on European Union (EU) and national regulatory matters involving medical devices and pharmaceutical laws and guidelines. Fabien follows the new regulations on medical devices (MDR and IVDR) and the GDPR very closely and regularly advises clients on the requirements applicable to their digital health technologies. With a practice entirely focusing on complex regulatory issues faced by Life Sciences clients, he can quickly address and anticipate complex challenges and propose innovative solutions enabling clients to focus on their business.
12:00 - 12:20
FEMSelect Case Study - How to Leverage Regulatory Pathways to Maximize your Go-to-Market Strategy
Through the case study of FEMSelect’s regulatory pathways in both the US and in Europe, I will share to what extent and how the regulatory pathways and the go-to-market strategies of the company were synchronized and how to leverage regulatory pathways to maximize a Go-to-Market strategy.
Debbie, Co- CEO of FEMSelect (women’s health medical device company) for the past 7 years, is an experienced healthcare executive with over 20 years of experience with commercialization of drugs, devices and HCIT. Debbie began her career at Eli Lilly and Company where she held a variety of brand management and sales management roles in the US and Global organizations. In her sales management role, Debbie led a team of 15 and was responsible for over $25M in sales. As a product manager, Debbie designed and executed a new product launch strategy that achieved reimbursement in the Israeli health basket. After 12 years at Lilly, Debbie joined iMDsoft as Director of Professional Services responsible for software implementation in hospitals through Europe, Israel and Australia. Before joining FEMSelect, Debbie served as the EMEA Regional Director for Avalere Health (healthcare advisory services) focused on reimbursement strategies for start-ups. Debbie received her BA from Harvard College and an MBA from The Wharton School.
Liat Aharon Pollak
Director Of Regulatory Affairs
12:20 - 12:40
EUDAMED Throughout the Life Cycle of Your Medical Device
The EUDAMED database aims to improve transparency and coordination of information regarding medical devices sold on the EU market. Once fully implemented, EUDAMED will provide data across the product life cycle for medical devices in the EU. MDR requirements challenge organizations to take a more holistic viewpoint of their products, resources, and regulatory toolkit and develop more proactive lifecycle strategies to maintain product compliance in the EU. In this presentation I will demonstrate how EUDAMED modules interact with the different phases of the device lifecycle, and how to embed these modules requirements in your existing lifecycle management process.
BIO:Liat is a regulation and quality assurance professional, with an extensive experience in medical device and pharmaceutical industries. In her role as the director of regulatory affairs in R.S NESS she leads regulatory processes in medical device companies and supports
customers in implementation of MDR requirements, including submission to global databases like EU EUDAMED and US FDA GUDID. Liat holds an M.Sc. from the Technion in Biotechnology.
Daniele Perl-Treves PhD.
RACL Consultant, Expert
12:40 - 13:00
CER Under MDR
The Clinical Evaluation Report (CER) is a crucial document for CE registration under the Medical Device Regulation (MDR). Compared to Clinical Evaluation Reports under the Medical Device Directive (MDD), the MDR introduced new and more stringent requirements for CERs.
Writing a comprehensive and effective CER requires a thorough understanding of the regulatory requirements and the scientific principles underlying clinical evaluation. A well-prepared CER should provide a comprehensive assessment of the device's safety and performance, based on a critical evaluation of the available clinical
evidence. The writing process should be systematic, transparent, and well-documented, and involve collaboration between the manufacturer and clinical experts. Attention must be paid to the quality and relevance of the clinical data and the scientific validity of the literature review, with an emphasis on the traceability of the data. Additionally, the CER should be continuously updated with new clinical data and post-market surveillance information.
In this presentation specific issues subjected to closer scrutiny from Notified Bodies under the MDR, such as literature search, analysis methodology, demonstration of equivalence and sufficient clinical evidence will be discussed.
Daniele Perl-Treves, PhD, has more than 15 years’ experience in the medical device industry. Daniele was Clinical Director of Radiancy, a global company specializing in medical and aesthetic skin care devices. Prior to that Daniele was project leader at OrSense Ltd, developing light based devices for non-invasive hemoglobin and glucose determination. Dr. Perl-Treves holds MSc and PhD degrees from the Weizmann Institute of Science and completed a postdoctoral fellowship in Cornell University (NY). She is also a certified CRA.
13:00 - 14:00 : Lunch, Exhibit Viewing
Head of Regulatory and Compliance
14:00 - 14:20
How to Stay Two Steps Ahead of the New Cybersecurity Requirements
As a device manufacturing organization, you don’t want to find your organization unprepared for the industry’s growing security requirements. To address the growing number of vulnerabilities in the majority of connected medical devices, the FDA will issue new cybersecurity guidance. This had already resulted in thousands of cybersecurity attacks. Both regulatory and governmental bodies are emphasizing the importance of manufacturers developing "secure-by-design" devices. This session will share insight on how to stay ahead of cybersecurity new requirements by sharing practical examples.
Shlomit received her BSc in Biology from Binghamton University. After moving to Israel in 2012 from New York, she spent 9 years working in medical device quality and regulation for companies such as Smart Medical Systems and Zebra Medical Vision Ltd. Shlomit is currently the Head of Regulation at Sternum IoT, focused on securing IoT medical devices from cybersecurity risks.
14:20 - 14:40
Electronic Quality Management System for Small Startups Companies
In the medical device industry Quality Management Systems include various processes such as: training management, supplier management, Equipment management, Non-conforming, CAPA, ECO, complaint management, etc. In order to manage the system properly, synchronization between processes is required as well as synchronization between all functions in the company, and ability to follow tasks and meet schedules. The best and most efficient way to do so is with Electronic Quality Management System.
Orcanos is an Electronic Quality Management System that allows the system to be configured according to company needs. LDP consulting adapts Orcanos Electronic Quality Management system and configured it to suit small Startups companies in the medical device industry, so you can cut onboarding time.
In this lecture we will present you LDP quality management system integrated into Orcanos platform.
Rotem holds a M.Sc. in Biotechnology and B.Sc. in Mathematics from Bar-Ilan University.
Rotem has 10 years of experience as QA/RA and Clinical Manager and consultant in numerous medical device companies. Her QA/RA experience includes establishment and maintenance of quality management systems in compliance with applicable regulatory requirements such as: ISO 13485, FDA QSR, and EU MDR requirements; management and supporting design control related processes, including establishment of the product’s DHF, involvement in risk management activities and V&V testing; supporting the production team in development and maintenance of the product’s DMR and manufacturing processes validations; and preparation and supporting regulatory submissions in different territories.
In addition, Rotem conducts internal audits, supplier audits and supports companies in preparation and management of external audits, performed by regulatory authorities.
Senior QA/RA and Clinical Project Manager
Vice President - Regulatory Affairs & Quality Assurance
14:40 - 15:00
SaMD and AI MedTech – How to Overcome the Core Regulatory, Quality and Manufacturing Hurdles?
This presentation will address the challenges faced by healthcare and MedTech businesses in the deployment of SaMD and AI technologies.
The topics of regulatory compliance, quality assurance, and manufacturing will be discussed, with a focus on overcoming core hurdles in these areas.
The importance of involving specialists, contract manufacturing, and a review of current procedures will be highlighted. Key areas to concentrate on will be discussed, including CE certification, clinical evaluation, IT and cybersecurity, design and risk documentation, and FDA and EU clearances.
The impact of remote auditing practices, the role of SMEs, and considerations for start-ups will also be covered. The ultimate goal is to provide actionable insights and guidance to ensure successful deployment of SaMD and AI technologies in the healthcare and MedTech industries.
Critical questions requiring prompt attention:
What steps can you take to ensure timely FDA and EU clearance?
Is a substantial infrastructure required to bring your technology to market?
Is your supplier prepared for unexpected audits?
Is your contract manufacturer compliant with ISO 13485 or MDSAP standards?
How ready are you for remote auditing processes?
As a start-up, are you following best practices to ensure success?
An expert in MedTech & Life sciences industry, Mr. Sundeep Agarwal is a speaker and trainer and Subject Matter Expert (SME) in the field of Regulatory Affairs, Quality Assurance, QMS, GMP, SaMD & Artificial Intelligence, Software Validation, IT Security & Cybersecurity, Drug-Device Combination, Design & development, Risk Management, Industrial Manufacturing and Clinical Studies. He is a lead auditor for medical devices and has expertise in ISO 13485, 21 CFR 820, EU MDR/IVDR, CE Certification, PMS, FDA Approvals & MDSAP certification. He has delivered multiple global webinars for medical devices, diagnostics and life science companies. He is currently associated with Remidio (which is into SaMD & AI devices), India as Vice President - Regulatory Affairs & Quality Assurance, apart from being an active member of a technical committee (Work Group - Software as Medical Device) at Global Harmonization Working Party. With more than a decade of experience and expertise, he serves regulators and industry professionals alike. He frequently contributes to global conferences in Europe, Canada and United States as speaker and panelist. A prominent guest lecturer in various MBA and Pharmacy educational institutions in India. Academically he holds a Master of Technology, MBA, a Post Graduate Dipl. in Medical Law & Executive Education on Quality Management and Manufacturing Strategy (IIM-A), India.
15:00 - 15:20
liberDi – FDA Clearance For Home Use – Personal Notes
liberDi is an innovative medical technology company pioneering a first-of-its-kind digital health technology to significantly increase the quality of life of patients, improve illness management and reduce the cost and complexity of delivering home dialysis. Our Digital Dialysis Clinic solution represents a significant technological disruption enabling novel, transformational dialysis care to accommodate patients with the portability and convenience to perform safe self-care dialysis exchanges in less than 25 minutes at their home, office, or while on vacation.
We will introduce you IDA, our - Intelligent Dialysis Assistant as well as the challenges we faced until our digital dialysis clinic was cleared by the US Food and Drug Administration (FDA) .
Mr. Tsoory has over two decades of experience of worldwide business, R&D, and global operations in both the healthcare and semiconductor industries. His solid background in both technology and management positions him to lead liberDi to success as an accomplished management executive with a track record in launching innovative systems to the market, with emphasis on medical device ventures.
Further, prior to co-founding liberDi, Mr. Tsoory held leading executive and C-Level management positions at companies such as PV Nanocell, D Medical Industries (TASE, NASDAQ: DMED), MCS (TASE: MDCL), Mentorwave, Power Paper, and others.
Mr. Tsoory holds a B.Sc in Mechanical Engineering from the Technion and M.Sc. in Management from the NYU School of Engineering.