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regulation 

Moderator:  Marina Lebel, VP Medical Device, Gsap

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Yael
Himmel Shlomo

Director Of
Regulatory Affairs

RS-NESS – Solutions For Life Science Companies
 

11:00 - 11:20

The IVDR Effects on Your Quality Management System:
Key Action Points

Are you preparing your In-Vitro Diagnostic (IVD) company for the new regulations in the EU (IVDR)?

90% of IVD companies selling product today to the EU, have a self-declared CE mark; Regulatory overview is minimal (by Notified Bodies) concerning the products technical documentation.

This is changing, due to the new regulations - IVDR; 90% of IVD devices are expected to be reclassified (due to new classification rules), which implies extensive changes in the Regulatory Documentation, Clinical Data, Quality System, and Validations. This surge of demand for Notified Body services is expected to create a bottleneck and could, for unprepared companies, prevent obtaining approval in a timely manner.

This presentation will provide key action items that your company should be implementing in the Quality Management System processes, in order to support the transition of your IVD products to the new EU regulation.
 

BIO:
As a Director of Regulatory Affairs, Yael brings to her role 10 years of industry experience in multi-disciplinary Medical Device companies.

Yael is experienced in leading regulatory processes in companies in different stages, managing and mitigating risks, and carrying discussions with different regulatory agencies. She helps our clients mitigate regulatory risks and navigate regulatory complexities, and develop regulatory strategies that go hand-in-hand with the client’s business strategies.
In the past, she has held top-level manager roles in the Medical Device and In-Vitro Diagnostics companies.

Yael graduated from  The Hebrew University of Jerusalem with a B.Sc degree in Biology and a M.Sc. degree in Structural and Molecular Biochemistry.
 

Dr. Einat Dekel
Medical Device Project Manager
Gsap

11:20 - 11:40

In Vitro Diagnostics (IVD)  - Main Design Risk Management Considerations - Analytical and Clinical Performance Studies (Design Validation)

The purpose of in vitro diagnostic medical devices (IVDs) is to provide information from human samples, such as blood and tissue, that allows conclusions to be drawn about, for example, physiological or pathological processes in the body.

This information is crucial for making a diagnosis and, therefore, for the further treatment of a patient.

The performance evaluation enable IVD manufacturers to ensure that the risks for patients have been minimized and that the information provided is correct and accurate, as well as, provides the intended clinical benefit.

Therefore, it is important that the performance evaluation is appropriately aligned with the risk management requirements.
 

BIO:

Einat has an extensive experience in managing all aspects of medical device/drug development including combination therapy and in-vitro diagnostics in the areas of pre-clinical and clinical trials in all stages of development, as well as, development and implementation of regulatory strategies, strategic thinking as for new therapeutic areas, assessment of safety concerns and risk analysis.

Prior to joining Gsap, Einat held a senior project management position at Teva and later on higher management positions at Sanofi and Protalix leading the medical, scientific and operational activities including business development interactions.

During her professional path Einat also gained experience in the Medical Device field leading the clinical development and regulatory activities in a Medical Device startup company.

Einat has high abilities in combining the quality assurance requirements with the regulatory requirements to tailor the pathway per each client specific needs.
 

 
 

Batia
Epstein-Buchnick

CEO

QMED-Lingua

Dina Sifri

CEO & Founder

MedDev Soft

11:40 - 12:00

Successfully Passing the Regulatory Barrier and Go-to-market Challenges - Tips For Localizing Medical Device and Clinical Documentation

Introducing a medical device to a new international market is a complex project, with many moving parts.
In this presentation, we will focus and address four specific challenges.

We will discuss how you can:

  1. Minimize the risk of liability exposure due to the wrong use of the product,

  2. Protect your brand reputation,

  3. Avoid delays in the market launch, and

  4. Ensure timely regulatory approval for your product.

BIO:
Developing long term relationships and teamwork is my personal and professional motto. Dedication to providing the best result, A-Z project management, that fits our client’s goals and needs, combined with true passion for language and the message it can carry.


 

12:00 - 12:20

AI Needs More Regulation,
Not Less

How regulatory processes are structured, and testing processes are tailored, promote the artificial intelligence industry and protect the public and promotes industry innovation
 

BIO:
One of the leading Israeli experts in the field of Medical Device Engineering, Software Development, all aspects of Medical and Pharma Software Regulation.
ME in Bio-Medical Engineering (Technion - Israel Institute of Technology), MBA for hi-tech industry (Technion - Israel Institute of Technology), MA & BA in Mathematics and Computer Science (Haifa University).

 


Yarden David

VP QA/RA

Medix Software

12:20 - 12:40

Cybersecurity Requirements
and Best Practices in
Medical Devices

Cybersecurity requirements for medical devices are getting more complex and taking more place in the regulation rules and submissions. Cybersecurity principles have a major impact on the final product itself, but also on the development process, company's procedures and post-marketing. Many of the medical device manufacturers are meeting cybersecurity requirements for the first time in the regulatory submission stage. From our extensive experience, taking cybersecurity requirements into account in the different product development stages can make the process easier and friendly and will prevent the frustration of implementing cybersecurity controls in the product design while it's already ready for release. Yarden will give you the best tips based on many successful cybersecurity projects and submissions
 

BIO:

Yarden has completed successfully her B.Sc degree in Biomedical Engineering at the Ben Gurion University of the Negev.

Since then she has been working in various medical device companies as a Quality, Regulatory and Clinical Affairs Manager. Yarden has vast experience with medical software development and cybersecurity requirements.

These days, Yarden is the VP Quality Assurance and Regulatory Affairs at Medix Software. Her professionality and ambitious are endless and for her the sky is the limit.
 


Moderator:

Marina Lebel

VP Medical Device

Gsap

12:40 - 13:00

Q&A Session

Moderated Q&A Session, with all five previous speakers:
 

Yael Himmel Shlomo, Director Of Regulatory Affairs, RS-NESS – Solutions For Life Science Companies

Dr. Einat Dekel, Medical Device Project Manager, Gsap

Batia Epstein-Buchnick, CEO, QMED-Lingua

Dina Sifri, CEO & Founder, MedDev Soft

Yarden David, VP QA/RA, Medix Software

Marina Lebel BIO:
Marina Lebel holds B.Sc in Chemical engineering from the Technion and a CQE certification from the American Society for Quality ASQ. Marina has over 20 years of experience in quality management, quality lectures, and quality and regulatory consultancy in various industrial fields, including Aerospace, Military, Medical devices, and Testing Laboratories. Marina led and managed the establishment of quality and regulatory systems for ISO 13485, AS 9100, ISO 9001 and ISO 17025.

13:00 - 14:00 Break, Exhibition Visit

 

Adam Samucha

QA Project Manager

Gsap

14:00 - 14:20

Application of Risk Management – New ISO 14971:2019 and Changes From Previous Revisions

ISO 14971 principles are implemented globally in the Medical Device Industry and conforming to the standard requirements is used to show compliance to regulation all over the world.

 Towards the transition to MDR (EU Medical Device Regulation) and IVDR (EU In-Vitro Diagnostic Regulation) and the recognition of ISO 14971:2019 by FDA, and other regulatory bodies, Medical Device companies must assess risk management processes and existing documentation.

We will review risk management principles and the major changes that differ the latest risk management standard.
 

BIO:

Adam has 12 years of experience in engineering and quality activities in medical device and pharmaceutical industry.

 He worked for and with several companies in R&D phases as well as in the feasibility and marketing stages, establishment of processes during design and product development, including writing DHF documents, such as dFMEA file, Risk management, Product validation and verification protocols and reports, Usability, Field support, Instructions for use.

Adam holds B.Sc. in Exact Sciences and works in Gsap since 2018
 


Dr. Naida Gurshumov

Senior Clinical
Project Manager
HaMaDa

14:20 - 14:40

Clinical & Publishing Strategy for Medical Device Companies

Throughout different stages of clinical development medical device companies deal with many challenging situations, including regulatory bodies, market needs, investors, physicians, QA audits, manufacturing, clinical trials and many others. The main focus of these activities is to finally provide sufficient clinical evidence, which will convince  physicians, regulatory bodies, investors and the company itself that the device is safe and successfully meets clinical needs. The main question however, is whether sufficient clinical evidence is equivalent to successful performance of clinical studies. Our presentation provide deep insight on this important question. Based on profound experience in the medical device industry, we believe that sufficient clinical evidence is much more than successful completion of clinical studies. It is composed of three successful strategies: clinical, regulatory and publishing strategies. While clinical and regulatory strategies represent the essence of every medical device company, its publishing strategies in many cases requires more attention. The presentation explains how to implement publishing strategy from the very beginning of clinical development and provides detailed answer regarding why, when and how to publish scientific, originated from medical device companies.   
 

BIO:

Dr. Naida Gurshumov holds a PhD degree from Tel Aviv University, Sackler Faculty of Medicine and has an extensive background in medical academia, in addition to holding high-ranking executive positions at leading international pharmaceutical, CRO and medical device companies. Her professional experience includes all stages of drug and medical device development, regulatory and quality assurance issues, scientific analysis and presentation of clinical data, setting up clinical departments, and writing numerous scientific articles for peer-reviewed journals.  

 

Michael Brun

Product Safety Group Manager & GMA Specialist
 Hermon Laboratories

14:40 - 15:00

Amendment to IEC 60601-1 – What Has A2:2019 Changed

Amendment 2 to IEC 60601-1 has entered the queue for harmonization and should be considered for update of existing products and the development of new products.

This Amendment is mainly an improvement of the current version. It includes the updates of references to other standards, and clarifications of the concepts. These improvements may not seem critical but they can affect the product design, for example the choice of components that must be approved to the relevant standards.

Also, this Amendment contains many small changes and provides further development of the standard in terms of Risk Control Measures (RCM). There may be some gaps related to compliance of specific medical product, and the responsible organization should be aware of these gaps and manage them in a timely manner.
 

BIO:

Michael Brun is Medical Regulatory Expert with over 25 years of experience in product safety, design, engineering and system integration. His expertise covers all phases of product design, with main expertise in Medical, Machinery and Laser product certification (Safety, EMC, Radio, Environmental). 

For last 12 years Michael Brun works in Hermon Laboratories Ltd, Israel as Safety Lab Manager and Senior Consultant for Medical Devices. He manages CB Test laboratory with dedicated medical team of experienced safety  engineers, and performs NRTL audits of manufacturers in Israel and abroad . Consult R&D teams of medical companies on regulatory requirements for products and processes in USA, Canada, Europe, Australia, Brazil and other countries.

Michael Brun made presentations and seminars for engineers and project managers on regulatory requirements for medical devices, participated in international IECEE conferences and meetings.
 

 

Roger Mazzella

Senior Product Manager

The Qt Company

15:00 - 15:20

Developing Certified Medtech Products with Qt

Whether you are developing FDA or EU Class II or Class III products such as surgical robots, infusion pumps, patient monitoring systems or medical imaging applications, Qt gives you the technology to make robust and reliable systems. What you create with Qt will not only impress your end users, but provide them with a natural and seamless user experience. During this session you will learn how Qt supports regulated medical product development, including:

Best practices for design for usability and human factors using Qt
Use cases for regulated medical products
What's built with Qt on the market today

 

BIO:

Roger Mazzella is a Senior Product Manager for The Qt Company, in charge of Qt’s cross platform UI/UX software for the medical industry. Roger has extensive experience in product and services management, regulatory law, compliance, and marketing for the medical device and diagnostics industry.  Prior to joining The Qt Company, Roger brought state-of- the-art regulatory and clinical software applications and services to the medical device and diagnostics industry and delivered quality engineering solutions and products for numerous multinational and Fortune 500 customers.  Roger received his Master’s degree in Biomedical Engineering from Worcester Polytechnic Institute, where his focus of study was on medical device design and FDA regulatory law.

Bosmat Friedman

Head of Clinical & Regulatory Services

ProMedoss, Inc.

15:20 - 15:40

Impact of Regulation on Innovation - Tips for a Successful Pitch

Any great idea for an innovative device requires funding in order to allow it to get to market and to the patients who need it. To do so, you have to approach investors – be it angels, early-stage, venture capital, or other type of investors – and present them with the most appealing plan. With the regulatory aspects being an essential part of the plan and, normally, a very demanding part of the budget, any “educated” investor will try mitigating regulatory risks by asking key questions like:    
Have you talked with the FDA to assess the regulatory pathway and requirements for this innovative device?
Have you outlined a regulatory strategy coordinated with your fundraising projections? 
Is your regulatory strategy created with consideration for exit opportunities along the way?
 
In this presentation we will provide you with tips for a successful pitch to investors and how to best utilize existing FDA processes to your advantage.

 

 

BIO:

Bosmat has been working as a regulatory consultant since 2007 initially as a consultant in Push-Med and subsequently as the CEO of MJ RAC. Bosmat has provided regulatory consulting services to medical device companies entering the US, European and Canadian markets. Under the guidance of Shoshana Friedman (Richard E. Greco Award recipient and RAPS Fellow) Bosmat has gained regulatory experience working with devices in a large variety of medical fields such as: GI, Neurology, Cardiology, Anesthesiology, Radiology/Imaging, In-Vitro diagnostics, and other. 
Bosmat holds a BFA from Concordia University (Montreal, Canada), a Practical Engineer diploma from Ort Technical College (Rehovot, Israel) and a MSc in Regulatory Affairs from Northeastern University (Boston, MA).

 


Moderator:

Marina Lebel

VP Medical Device

Gsap

15:40 - 16:00

Q&A Session

Moderated Q&A Session, with all five previous speakers:
 

Adam Samucha, QA Project Manager, Gsap

Dr. Naida Gurshumov, Senior Clinical Project Manager, HaMaDa

Michael Brun, Product Safety Group Manager & GMA Specialist, Hermon Laboratories

Roger Mazzella, Senior Product Manager, The Qt Company

Shosh Friedman, CEO, ProMedoss, Inc.

Marina Lebel BIO:

Marina Lebel holds B.Sc in Chemical engineering from the Technion and a CQE certification from the American Society for Quality ASQ. Marina has over 20 years of experience in quality management, quality lectures, and quality and regulatory consultancy in various industrial fields, including Aerospace, Military, Medical devices, and Testing Laboratories. Marina led and managed the establishment of quality and regulatory systems for ISO 13485, AS 9100, ISO 9001 and ISO 17025.