Quality & Regulation Track

Sponsored by:

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Moderator: Marina Lebel, VP Medical Device, Gsap

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Michael Kasser

Director of Regulatory Sciences

Hogan Lovells

11:20 - 11:40

De Novo – No longer That New

FDA has been increasingly embracing the de novo process, with devices that previously would have required a PMA being able to go through this moderate risk pathway. But there has also been an increase in devices that previously would have been a 510(k) now going through this pathway. The lecture summarizes the impact to regulatory timelines, data requirements, and cost of going through the increasingly common de novo pathway.

  

BIO:
Michael (Moshe) Kasser is Hogan Lovells representative in Israel. He is a former FDA premarket reviewer that has been assisting Israeli companies clear FDA hurdles and bring novel technologies to the US market for the past 8 years.

 

11:40 - 12:00

Appointing Your Digital Health EU Suppliers Avoiding Legal Hazards of MDR and IVDR

EU MDR and IVDR have introduced new obligations on economic operators.  Economic operators include an importer (required for overseas manufacturers), distributors and your authorised representative.   Manufacturers are obliged to supply information and documents to their appointed economic operators.  Manufacturers need to know how to control quality through their supply chain and to manage these economic operators in their dealings with regulatory authorities.  This talk explains the requirements and challenges, and offers practical solutions for manufacturers of digital health medical devices and in vitro diagnostics.

BIO:
Alison co-heads the international life sciences team. Alison provides sophisticated counsel on regulatory, compliance and commercialisation, as well as intellectual property transactions. During her 20 year career, Alison has advised on individual advertising campaigns and promotion of clinical trials. Alison has also advised on and drafted EU-wide policies on HCP and HCO in compliance with the complex framework of EU regulations, national laws and industry and deontological codes.

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Alison Dennis

Global Co-Head of Life Sciences, London

Taylor Wessing

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Daniel Liezrowice

Managing Partner

ESL - Engineering Software Lab

12:00 - 12:20

Using Static Analysis Techniques For FDA  and IEC 62304 Source Code Compliance

How Static Code Analysis will help you to achieve FDA compliance and Prepare Your Medical Device Software for the New FDA Cybersecurity Guidance  by scanning your source code according to the FDA guide lines.

The presentation will include a live demo on stage using real code in a typical Medical Device software development environment.
 


BIO:
Daniel is a development tools specialist at ESL, the Israeli reseller of Qt and Parasoft, his role is to deploy,  integrate SW development Tools and train the Software Development teams of  Medical Device companies on the usage of the tools in creating Certified Medical Devices.

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Margalit Anukov

VP QA/RA

Matrix Medika

12:20 - 12:40

Cybersecurity: Never an Afterthought, How to Ensure Security and Compliance for
FDA/CE Approval

The FDA and CE enforce strict cybersecurity standards, and demonstrating compliance is a challenge  many companies face in the submission approval process. These standards are crucial because  data and system breaches in healthcare software can seriously endanger patient health and privacy. Such breaches can also destroy user trust and cost companies billions of dollars a year. 

In this lecture you will learn how to ensure that your healthcare product is secure from the very beginning – and how to implement and document  HIPAA, GDPR and IPPR compliance, penetration testing, code vulnerability scanning, and other cybersecurity measures for successful CE and FDA submissions.
 

BIO:
With over 10 years of experience in Quality Assurance and Regulatory Affairs in the healthcare industry, Margalit manages the QA/RA Team at Matrix-Medika, helping healthcare companies implement critical V&V processes including software QA, regulatory assessments, information security, privacy and cybersecurity assurance.

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Yael Himmel-Shlomo

Director Of Regulatory Affairs

RS-Ness

12:40 - 13:00

Regulatory Navigation Tools for R&D Managers

As medical devices developers, regulatory approval is one of the key product deliverables for a company. 
Having a good strategy, and knowing how to navigate the regulatory path, can save costly time in the development process, and help align your Product features with the safest and shortest path to market. 
During the presentation we will discuss features that may affect the risk classification (and testing overhead) of product/SW features, regulatory aspects of Product Management (such as Usability testing, and Design Control methods to make your FDA/CE submission easier) and surprising ways you find competitor's information. 
This presentation is best suited for R&D and Product Managers, QA/RA personnel handling Design Controls, from Medical Device and Medical SW companies.



 BIO:
Yael is experienced in leading regulatory processes in Medical Device 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 multi-disciplinary Medical Device and In-Vitro Diagnostics companies.

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

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

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Ophir Benjamin Gamliel

CEO

ITL- Israel Testing Laboratories

14:00 - 14:20

Faster FDA Premarket Submission Via FDA - Accreditation Scheme for
Conformity Assessment (ASCA) Program

FDA has initiated an Accreditation Scheme for Conformity Assessment (ASCA) program to facilitate the review process in a premarket submission. As a part of this program, FDA qualifies laboratories that perform the testing according to FDA requirements

ITL is the only FDA-approved ASCA laboratory (number 23) in Israel addressing Basic Safety and Essential Performance standards included in the ASCA Program.

Device manufacturer that joins the FDA ASCA route benefits a much faster and a smooth FDA review process with no requests for further testing information.

The submission package includes an  ASCA summary test report (prepared by ITL), manufacturer Application and Declaration

ITL has a long and vast experience in testing of Medical Devices and now can allow manufacturers to join the FDA ASCA program
 

Ophir Benjamin Gamliel BIO:

Ophir is ITL’s CEO since 2006. He holds a B.Sc. in Electrical Engineering from the University of Maryland and a M.Sc. in Computer Science and Communications from Johns Hopkins
University in Baltimore.


Ophir has a diverse global experience. He held positions, in the US, as a senior engineer at Cisco Systems Inc. and Sprint Inc., and as Sales Director at Nortel Networks Inc. in Virginia. In addition, Ophir served as a Senior Manager at Cisco Systems Israel Ltd., and Vice President Sales at Globcall, a subsidiary of IDB Holdings Company Ltd.


Ophir has lead the Opening of the Market Access to Israel to Private Laboratories by changing the Regulation in Israel working with the Israeli Ministries and the Parliament.

 

Slava Pilyagin BIO:

Expert Product Safety Engineer & Team Leader of Medical Device,
Household, Laser and Photobiological Safety Departments.
Holds a B.Sc. in Electrical Engineering from the SCE Sami Shamoon College of Engineering.
Expertise in Guidance for R&D engineering/QA/RA teams for global compliance requirements and Support of manufacturers in regulatory needs.

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Slava Pilyagin

Safety Compliance Team Leader

ITL- Israel Testing Laboratories

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Batia Epstein-Buchnick

CEO and CLO

QMED-Lingua

14:20 - 14:40

Crossing Regulatory Barriers and Go-to-market Challenges - Tips For Localizing Medical Devices
and Clinical Documentation

Introducing a medical device to a new international market is a complex project, with many moving parts.
The focus will be on 5 specific challenges:
- Minimize the risk of liability exposure 
- Protection of brand reputation
- Reduction of time to market
- Ensure timely regulatory approval for your product
- Effective budget issues



BIO:
Batia is the CEO and CLO (Chief Language Officer) of Q-Lingua Translation and Localization Services and of QMED-Lingua, the Life Sciences Division of the company. Batia holds BA and MBA degrees, including extensive background in the global business development sector, where she held senior roles in the technology, security and life science sectors. For the past 12 years, Batia provided localization and strategic consulting services to prominent clients, and co-founded Q-Lingua and QMED-Lingua with her partner – Gabriel Rymberg. The DNA of the company is based on combination between true and deep passion for language with excellent customer service, dedication to each client and their objectives, out of a sense of true partnership. From Facebook and Bayer to Israeli Medical Device Startups – each client is put at the center, and gains customized service and personal attention.
 

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Michael Brun

Group Manager & GMA Specialist

Hermon Laboratories & Qualitech

14:40 - 15:00

Transition to MDR - Conclusions and Action Items

The deadline for transition from MDD to MDR has passed in May this year, and most manufacturers have successfully completed the transition.

However, many medical companies found that product compliance based on “placeholder” evidence does not work any longer. Regulators are questioning both “old” and “new” evidence, and the fact it was accepted before does not necessarily mean it would be accepted again.

What are the critical compliance issues raised during the transition? What may come up during next audit? Presentation looks into most common issues related to Medical Device life cycle, as seen by Hermon Laboratories - the biggest private lab in Israel.


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 14 years Michael Brun works in Hermon Laboratories Ltd, Israel as EMC and Safety Lab Manager at Petah Tikva site (Qualitech) 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.
 

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Ziva Shalev

Standardization Project Manager
The Standards Institution
of Israel

15:00 - 15:20

International Standardization of Medical Devices

I shall survey the main international organizations preparing International Standard for Medical Devices,

- The Technical Committees and Workgroups within these organizations that work on Medical Devices standardization; their structure, the specific devices that each committee and workgroup specializes in,
- The international standardization process,
- International standards for Medical Devices that are currently under development,
- Joining the International standardization process.


BIO:
Electricity and Electronics Engineer from the Tel-Aviv University (B.Sc.)

Project manager at the IDF-Navy (EW),

Circuit developer and Engineering at the Tadiran V.H.F. plant,

Technical writer

Specifications Department, Quality Assurance Department and Value Added Services Departments at Bezeq Corporation

Standardization Division at SII
 

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Moshe Radovitch

IT/OT & Quality Director
Origami Information Systems

15:20 - 15:40

Covid 19, Quality Challenges, and Automation Technologies Engagement

Medical Device companies experienced many impacts from Covid-19 on customers, internal operations and supply chains.

Communication and visibility are more important than ever before to mitigate risks and manage issues after the most critical stages of the pandemic.

In this talk, we share some practices adopted by our medical device clients: 

- Engaging with customers when there's uncertainty in their demand, or your supply
- Adapting and even improving processes for work from home, hybrid, and essential manufacturing personnel
- Identifying and mitigating risks in supplier delivery
- New Quality Management metrics and practices from the pandemic that are likely to continue


BIO:

Director of IT/OT & Quality at Origami Information system, an expert with 25 years in global Biomed and High-Tech organizations in various roles. Managing and executing diverse, complex, and innovative projects in multi-site international environments, including budget planning & management. Development, implementation, and maintenance according to organizations disciplines (Engineering, Production, QA, Validation, Operation, Supply Chain, Management)

Experienced Subject Matter Expert (SME) of Computer Systems, assisting and attending audit inspections.