Quality & Regulation Track
Director of Regulatory Sciences
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.
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
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.
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.
12:20 - 12:40
Cybersecurity: Never an Afterthought, How to Ensure Security and Compliance for
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.
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.
Director Of Regulatory Affairs
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.
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
Ophir Benjamin Gamliel
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.
Safety Compliance Team Leader
ITL- Israel Testing Laboratories
CEO and CLO
14:20 - 14:40
Crossing Regulatory Barriers 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.
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
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.
Group Manager & GMA Specialist
14:40 - 15:00
Transition to MDR - Conclusions and Action Items
Abstract - TBD
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.
Standardization Project Manager
The Standards Institution
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.
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,
Specifications Department, Quality Assurance Department and Value Added Services Departments at Bezeq Corporation
Standardization Division at SII
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
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.