Quality & Regulation Track
Moderator:
Ira Hadas, B.Sc, HC-MBA
Quality & Regulatory Affairs Specialist - Medical Devices
Dr. Dorit Nahari
VP Global Quality and Regulatory Affairs
Insightec
11:20 - 11:40
Change Control - Friend or Foe?
The role of a robust, well‑structured change control process in the lifecycle of complex medical devices such as Insightec’s Exablate Neuro/Prime system is critical. The operational need for clarity and consistency internally, is balanced with navigating the external regulatory expectations of agencies such as the FDA.
This process requires thorough, documented, multidimensional impact and risk assessments—including safety, effectiveness, labeling, software, and hardware—followed by appropriate regulatory pathway determination.
While organizations aim for internal simplicity, speed, and predictability in change execution, manufacturers face the dual challenge of external regulatory scrutiny. The FDA and other authorities review changes retrospectively, and disagreements regarding classification or assessment can lead to costly consequences.
While Annual Reports are an efficient path, they carry inherent compliance risk; correct regulatory categorization, strong technical justification, and cross‑functional collaboration are essential defences against regulatory challenges.
BIO:
Dr. Dorit Nahari is a Food and Biotechnology Engineer and has a PhD in Molecular biology. She has 20 years’ experience in the highly regulated health industry of both biological products and medical devices. She held various senior management positions in Quality, Regulatory and Operations as part of global organizations. She has extensive experience working in GMP and ISO 13485 regulated environments, including leading successful FDA and MDR audits and supporting numerous submissions to these and other regulatory agencies. She is currently with Insightec as VP Global Quality and Regulatory affairs.
11:40 - 12:00
USA Here We Come - The Story of Pulsenmore ES De Novo Approval
Israel A. Citron MBA, MSc
Vice President Regulatory Affairs and Quality Assurance
Pulsenmore
Pulsenmore submitted its first of its kind “Home Ultrasound system” to the FDA via a De Novo route. The De Novo order was received at the end of October 2025.
How to build a solid De Novo submission project. What surprises we encountered. Can we anticipate obstacles? How we prepared plan B that works. Some insights we gained during the journey to the successful designation grant.
This short lecture will tell the story of a successful journey towards the De Novo approval and share insights from our experience.
BIO:
Over 25 years of experience in management of regulatory affairs and quality assurance in corporate and startup medical device companies.
Active participant in international standardization organizations.
MSc in Electrical Engineering, Technion - Israel Institute of Technology; MBA, Tel Aviv University.
12:00 - 12:20
Cybersecurity Processes Across the Lifecycle - Security Built-In, Not Bolted-On
Margalit Anukov
VP QA/RA
Matrix Medika
This session examines how cybersecurity is systematically integrated throughout the entire medical device lifecycle—from initial concept and architectural design through development, verification, deployment, post-market surveillance, and end-of-life. Rather than treating cybersecurity as a one-time compliance activity, the session highlights a continuous, risk-based approach aligned with regulatory expectations. Practical examples will illustrate how to build security in from the outset, maintain it through updates and changes, and responsibly manage cybersecurity risks through product maintenance and retirement.
BIO:
Experienced QA/RA professional with over 15 years of experience, including five years as VP at Matrix Medika. Specializes in Software QA/RA, cybersecurity, and information security. Holds a B.Sc. in Biotechnology from Ben-Gurion University, with a strong background in the pharmaceutical and medical device industries, including ISO 13485, ISO 14971, IEC 62304, FDA QMSR, MDR, and global regulations.
Becky Moses
Human Factors Practice Leader
Core Human Factors
12:20 - 12:40
De-Risking Your Use-Related Risk Analysis: Human Factors guidelines for Regulatory Compliance
Human factors engineering focuses on creating safe and effective medical devices by understanding user interactions and reducing use-related risks through design. The risk management process, particularly for use-related risks, can differ from other risk analyses that a manufacturer creates. It can be challenging to translate ISO 14971–based risk management into an FDA-compliant use-related risk analysis. This presentation clarifies key regulatory differences, common errors, and practical strategies for meeting FDA human factors expectations.
BIO:
Becky (Rebecca Moses) is a Human Factors Practice Leader at Core Human Factors, A Rimkus Company. With over 13 years at Core, Becky specializes in researching the safety and usability of medical devices and combination products. For the past 8 years, she has led Core’s Israel office, supporting clients worldwide with human factors planning, consulting, and regulatory strategy, resulting in successful approvals and clearances of medical devices. Becky has lectured at conferences across the US, Europe, and Israel. She holds a Bachelor of Science in Engineering (B.S.E) in bioengineering from the University of Pennsylvania.
Fatimazahra Meskini
Certification Manager
GMED
12:40 - 13:00
​Is Europe Still Worth It? MDR, IVDR, and MDSAP as Strategic Market Access Levers
Beyond the Checklist : Why Regulatory Submission of Medical Device Software Requires More Than Expected
Following the publication of the latest European regulatory texts clarifying notified bodies’ practices on timelines, costs, and re-certification, the MDR and IVDR are directly impacting manufacturers’ global market access strategies. From the perspective of a Notified Body, this session highlights how these changes are reshaping decisions to enter the EU market and how market strategy and experience gained through MDSAP as a regulatory pathway in different countries can be leveraged as a strategic global market access pathway to mitigate complexity and accelerate international expansion.
Fatimazahra Meskini BIO:
Fatimazahra Meskini is a Certification Manager and experienced Lead Auditor at GMED. She is a Biomedical Engineer by training and has extensive expertise in auditing and regulatory compliance for medical devices. With a strong background in quality management systems and conformity assessment, Fatimazahra supports manufacturers in achieving CE Marking and maintaining compliance under the EU MDR.
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Hussein Shakir BIO:
Hussein Shakir is a Business Development Specialist at GMED North America, supporting medical device manufacturers with regulatory and certification strategies across global markets. He works closely with startups and established companies to navigate conformity assessment pathways, accelerate market access, and align technical, quality, and commercial objectives. Hussein brings a strong customer-centric approach and enjoys building long-term partnerships within the international medical device community.​​​​​
Hussein Shakir
Business Development Specialist
GMED
13:00 - 14:00 : Lunch, Exhibition Visit
14:00 - 14:20
How to Navigate the Usability Journey? Hard-Won Lessons for Israeli Med-Tech
This talk addresses a recurring dilemma in MedTech: how to balance rapid innovation and limited resources with the need for a comprehensive human factors process.
While this challenge is global, Israeli companies often face added complexity due to the distance between local development teams and U.S. end users, making early usability decisions especially critical.
Drawing on real-world examples and case studies, we will examine key decision points: when to involve usability and human factors experts, how to conduct formative studies in Israel, and when remote usability testing is appropriate.
Join us to gain practical, experience-based insights for navigating these trade-offs while maintaining regulatory compliance and delivering effective, usable products.
BIO:
Yael is a cognitive psychologist with over a decade of experience leading research on human behavior and decision-making. As a UX and usability expert, she brings extensive experience in leading comprehensive usability processes, applying cognitive psychology principles to the design, evaluation, and validation of complex medical systems.
Her work focuses on bridging the gap between product development teams and real-world user needs, ensuring that design decisions support clarity, safety, and effective decision-making in demanding environments.
Yael holds a PhD and an M.Sc. in Cognitive Psychology and Human Factors Engineering from the Technion.
Yael Shavit, PhD
Senior Usability & UX Expert
Cognit UX Experts
Sharon Konforty Wissmark
Project Manager, Lead auditor and Technical documentation Reviewer
DEKRA Certification
14:20 - 14:40
The Future of Medical Device Regulation: Navigating the MDR/IVDR 2.0 Revision
This lecture will provide an overview of the newly discussed updates regarding the revision of MDR (EU) 2017/745 and IVDR (EU) 2017/746, following the proposal published by the European Commission on 16 December 2025. Based on a targeted evaluation identifying unnecessary administrative burdens, the revision aims to simplify rules and enhance the predictability and cost-efficiency of the certification process, particularly for small and medium-sized enterprises. A key highlight of the session is the introduction of "Breakthrough" and "Orphan" device designations. Finally, the session will outline the anticipated legislative timeline.
BIO:
Sharon Konforty Wissmark is a project manager, Lead Auditor and technical documentation reviewer with over 20 year of experience in the medical device industry, For active and non-active devices, Sharon also holds an MSc in Industrial engineering.
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Michael (Moshe) Kasser
Senior Director of Regulatory Strategy
Hogan Lovells
14:40 - 15:00
FDA Pressure Points of AI Regulation
The integration of AI in medical devices has presented new challenges to the FDA regulatory process, leading to unique pressure points and sensitivities that should be addressed in marketing submission. This lecture reviews these points and provides best practices to smooth the regulatory process.
BIO:
Moshe Kasser has been involved in the regulation of medical devices since he obtained his Ph.D. in materials science and engineering. His thesis focused on novel materials used in joint replacement, and upon graduation, he immediately put this knowledge to use at the FDA as a scientific reviewer of orthopaedic devices. Michael brought a powerful and unique blend of regulatory know-how and technical understanding required to comprehend and address the FDA's scientific concerns with novel technologies.
Today, Moshe 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 communication skills to assist medical device companies to clear FDA hurdles and bring novel technologies to the U.S. market. This includes cutting-edge technologies such as brain/computer interfaces, robotic surgical systems, cartilage replacement devices, wearable sensors, digital health, and many others.
Michael provides deep technical knowledge in the areas of mechanical testing, MRI safety testing of implants, biocompatibility testing, chemical characterization, and electrical testing. He published articles in both scientific and regulatory journals on a variety of topics. His favorite hobby is boardgaming with friends.
Dr. Dagan Harris, PhD, MHA
VP Clinical & Regulatory Affairs
Theranica Bio-Electronics
15:00 - 15:20
From Vision to Implementation and Success. The FDA Regulatory Journey of Theranica From Then Till Today
The lecture will review the path Theranica took from idea to product, regulatory planning and discussions with the FDA regarding the route, the clinical studies conducted for each regulatory approval, the various submissions to the FDA and ways to resolve disputes with the FDA
BIO:
Dr Dagan Harris serves as the VP of clinical and regulatory affairs at Theranica Bio-Electronics, which develop the first wearable device for the treatment of migraine. Dagan has over 25 years of experience in the medical device field, in particular executing clinical trials and regulatory submissions all over the world. Dagan serves as clinical application manager in MindGuard and UltraShapeand as VP of clinical and regulatory in NanoVibronix, Orsan Medical, Medasense Biometrics