Quality & Regulation Track

Sponsored by:

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Moderator: Marina Lebel, VP Medical Device, Gsap

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Dr. Tami Siniaver

Quality and Regulatory Project Manager

Gsap

11:20 - 11:40

IVDR EU – In Vitro Diagnostic Regulation in the EU

How does the new EU regulation of the In Vitro Diagnostic Devices will affect the manufacturer and the whole field  

  • What is In Vitro Diagnostic Medical Device -IVD

  • Short Explanation about the change in Europe

  • Directive IVDD vs. Regulation IVDR

  • Time lines, Classification of devices and Main Requirements according to IVDR

  • Legacy Products Under IVDR

  • General Safety and Performance Requirements- GSPR

  • QMS under IVDR

  • Risk management for IVDR

  • Performance evaluation and Post marketing surveillance

 

BIO:
Dr. Tami Siniver is a veterinarian by profession, previously serving as a CRA and in charge of preclinical trials in Edwards life science. Engaged in quality project management and regulation of medical devices at Gsap.

 

11:40 - 12:00

Current FDA Premarket Trends and Timeline

This lecture summarizes the current challenges most often raised during review of premarket FDA submissions and how to address them. It also summarizes current review times and success rates for 510(k) and de novos.

BIO:
Michael (Moshe) Kasser has been involved in the regulation of medical devices since he obtained his Ph.D. in materials science and engineering. He brings a powerful and unique blend of the regulatory know-how and technical understanding required to comprehend and address the FDA's scientific concerns with novel technologies. Michael has combined that understanding with a knack for explaining technical concepts in a way that both the industry and FDA can easily understand. He uses his knowledge and communications skills to assist medical device companies to clear FDA hurdles and bring novel technologies to the U.S. market

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Michael Kasser

Director of Regulatory Sciences

Hogan Lovells

12:00 - 12:20

Regulatory Technology - Introduction to Regulatory Management System and Software
 

Thousands of regulatory affairs professionals worldwide turn to advance SaaS solutions, that had proven to streamline market clearance processes,
significantly reducing the overall burden and cost. 
By attending this short 20min demonstration, you will have the opportunity to learn how you can:

  • Start a new device-specific registration application of your product to any country worldwide in less than five minutes.

  • Complete and submit said application to local authorities in most countries in approximately 30 working days or less.

  • Get your product market access four months in advance.

  • Do all the above without the need for a local distributor

BIO:
Yoav Madai - Business Development Manager in the Arazy group, drives sustainable financial growth through boosting sales and forging strong relationships with clients. Working closely with the Asian & European markets with high attention to the Israeli manufacturers. 

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Yoav Madai

Business Development Manager

Arazy Group

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Yaron Ziv

Presale Manager

DOT Compliance

12:20 - 12:40

Supplier Management in the New World

The last two years showed us that we need to increase the number of our suppliers and to be more "hands on" regarding their activity. How can an organization handle these two new challenges without chasing their own tail.
 

BIO:
Yaron is a pharmacist and MBA with more than 10 years in the pharmaceutical and medical device industry. Yaron was VP Quality of Novolog and of Chemipal. Yaron is an expert in implementing QMS in organization according to the ISO 9001 and 13485.

Nikitin Anthony

Medical Device Compliance Team Leader,

Carmel Laboratories

12:40 - 13:00

How to Start a Project With a Lab on the Right Foot

How to start a project with a lab on the right foot.

A lot of unnecessary headaches can be avoided when the manufacturer is properly prepared for the submission.

During this lecture, several ways to shorten the testing time and lessen the amount of communications with laboratory will be discussed. By doing so you could save valuable time and money.

 

BIO:
Experienced engineer with years of experience with Medical equipment, Laser and Photobiological compliance. Has finished hundreds of projects resulting in IEC and CB certificates. Some of the projects have been submitted for NRTL listing and have been approved. Has been providing guidance on preparation of test plan for EMC testing and integration into safety. Has provided professional support during communications and submissions to FDA and notified bodies. Over the years provided guidance for industry on compliance. Lectured during different seminars, expositions and webinars. Has been the moderator during MDI exposition (2019) on medical device design track.

 

 

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13:00 - 14:00 : Lunch, Exhibit Viewing

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Shlomit Cymbalista

Head of Regulations

Sternum

14:00 - 14:20

Regulatory Spotlight on Cybersecurity- Are You Ready?

You don't want to find your company unprepared for the industry's growing security requirements! 
Last month the FDA released the newest cybersecurity guidance to meet the growing number of vulnerabilities in the majority of connected medical devices which have resulted in thousands of cybersecurity attacks. Both regulatory and governmental bodies have started putting greater emphasis on manufacturers developing "secure-by-design" devices, and we at Sternum will help you get there.

BIO:

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. 

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Efrat Hartog-David, Ph.D
VP of Regulatory Affairs and Quality Assurance

MeMed Diagnostics

14:20 - 14:40

MeMed’s Journey: Impacting Patients’ Lives by Transforming an Idea Into a Cleared FDA Product
 

MeMed is a leader in the emerging field of advanced host-response technologies. Its mission is to translate the immune system's complex signals into simple insights that transform the way diseases are diagnosed and treated. MeMed has developed a first-of-its-kind in-vitro diagnostic test that decodes the immune response to accurately distinguish between bacterial and viral infections, within minutes and as such is aimed at improving patient care and outcome. To overcome the regulatory barrier associated with such an innovative medical product, MeMed has developed and executed a comprehensive regulatory strategy. The process included extensive interactions with FDA under the pre-submission framework, as well as design and execution of thorough analytical and clinical studies. It has been a long journey starting out with a concept and transforming it into an FDA cleared product that impacts patients’ lives. In this presentation, the major milestones and key takeaways from this exciting journey will be shared.


BIO:
Efrat Hartog-David, VP of Regulatory Affairs and Quality Assurance at MeMed has over a decade of experience in Quality Assurance, Clinical and Regulatory Affairs. She has managed product lifecycle quality and regulatory submissions for clearances of numerous medical devices in the US, EU, China, and rest of the world. Before joining MeMed, Efrat was Regulatory Affairs Manager at GE Healthcare, responsible for leading and executing the global regulatory strategy for the Nuclear Medicine business. As part of her role at GE Healthcare she led a team responsible for providing leadership and guidance on global compliance, developing global regulatory strategies and plans, and preparing regulatory submissions and worldwide registrations. Efrat has also served as Regulatory Affairs specialist at Philips Healthcare, where she was the regulatory lead for programs aimed at introduction of new product, and played a key role in internal and external audits. Prior to that, Efrat served as a consultant for a wide range of medical device companies, focusing on clinical study design, quality system management, and regulatory strategy development and execution. Efrat holds a B.Sc. and Ph.D. in Biotechnology and Food Engineering from the Technion, Haifa, Israel.

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Steli Loznen, M.Sc., IEEE-SM

Vice President For Technical Activities

IEEE-PSES

14:40 - 15:00

Blueprint For IEC 60601-1 Edition 4 Standard
 

For Medical Electrical Equipment (MEE) the main applicable harmonized international standard is represented by IEC 60601-1 general standard in conjunction with the collateral (60601-1-x) and particular (60601-2-y) standards. The actual used general standard is the third edition published in 2005 in addition with Amendment 1 from 2012 and Amendment 2 from 2020, that arrived now in a point which need changes due to technical progress and extension of the medical procedures. 
The presentation focuses in the new architecture of the upcoming edition 4 of the general standard scheduled for 2025. The changes refer to the philosophy of the requirements for compliance and product safety based on the systemic correlation of the possible causes of accidents and harms caused by MEE and the design and use of these equipment. These changes consist in rethinking of the structure of the standard and how the included requirements will provide a more elevated level of protection on use of MEE.
The IEC 60601-1 users need to be ready from now to understood the up-dated philosophy and to learn, even from today, the news issues and to implement these in the future new projects.


BIO:
Steli  Loznen, M.Sc, Senior Member-IEEE, is a well-recognized international expert in Standardization of Medical Equipment. He received his M.Sc. in Electronics from the Bucharest Polytechnic University, Romania in 1974. 
As Israel representative, has been involved in the IEC international standardization on medical equipment as Convener and Project Leader. In 2017, in recognition for these activities, he was awarded with the IEC “1906 Award”.
He participates as Lead and Technical Assessor for IECEE-CB Scheme, member of Experts Evaluation Team of European Commission for Nanotechnologies, member of A2LA Accreditation Council, member on the editorial board of Medical Devices Technology magazine (U.K.) and from 2012 Member of Board of Governors of IEEE-PSES, Chair of Israeli Chapter IEEE-PSES and from 2019 V.P. for Technical Activities IEEE-PSES.  
From 2018 he is Honorary Member of Israeli Society on Medicine and Biology Engineering (ISMBE). 
Among his 8 published books the most substantial is his contribution as first author for “Electrical Product Compliance and Safety Engineering” – 2017 (vol. I) and 2021 (vol. II) published by Artech House (London-Boston). Steli Loznen authored more than 44 publications in magazines and conference proceedings and contributed more than 110 presentations at seminars and conferences.

 

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Shay Levav

VP Quality Assurance, Regulatory Affairs and Clinica
lIceCure Medical

15:00 - 15:20

FDA’s Breakthrough Device Designation Program

  • A review of what the FDA Breakthrough Device Designation Program is

  • Criteria and approval process

  • Lessons learnt and the benefits of this program to companies

  • How this program would help to get market approval for the device

  • Next to come for Breakthrough devices (TCET – Transitional Coverage for Emerging Technologies)


BIO:

Vast experience of over 20 years in Quality, Regulatory, Processes Improvements and leading cross organization projects

VP Quality Assurance, Regulatory Affairs and Clinical at IceCure Medical, since September 2020, leading the company compliance and clinical affairs

Prior to joining IceCure Medical, held a position of Director of Quality, Regulatory and Customer Support at Applied Spectral Imaging (ASI) and Several positions at Carestream Health (formerly Orex Computed Radiography).