Quality & Regulation Track
Sponsored by:
Moderator: Iris Shamir, VP Pharma Quality & Medical Device Quality & Regulation, Gsap
Dana Manaim Tirosh
QA RA Senior Project Manager - EU MDR SME
Gsap
11:20 - 11:40
Navigating EU MDR Technical File Submissions – Lessons Learned
The presentation shall provide critical insights into successful EU MDR documentation strategies. Drawing from extensive industry data and real-world experiences, this session explores why approximately 80% of Technical Documentation submissions are deemed incomplete by Notified Bodies, leading to significant delays and increased costs. Learn proven approaches to avoid common pitfalls, understand crucial documentation requirements, and master the interconnections between critical documents.
The presentation offers practical guidance on preparing comprehensive Technical Documentation that aligns with MDR requirements, featuring strategies to reduce review cycles and accelerate time-to-market while maintaining compliance with evolving regulatory requirements.
BIO: Dana is a Medical Device Regulatory and Quality expert specializing in EU MDR. As a Senior Project Manager at GSAP, Dana gained extensive experience managing complex regulatory projects; Dana has successfully led multiple EU MDR technical file submissions, achieving certifications with notable efficiency.
At GSAP, she has guided numerous manufacturers through the MDR transition process, providing strategic oversight for technical documentation preparation, remediation, and successful submissions with a proven track record of successful interactions with Notified Bodies.
As an instructor at Gstudy training center, she regularly conducts training on EU MDR requirements and technical documentation preparation, sharing practical insights from her extensive field experience. Her deep understanding of regulatory requirements and technical documentation best practices makes her a valuable resource for manufacturers navigating the complexities of EU MDR compliance.
11:40 - 12:00
AI Tools in SW Validation
Yael Nuss
SW Validation Expert
R.S NESS Group
The engaging lecture explores cutting-edge AI tools and their role in streamlining software validation processes. The presented tools are specific to Life science industries and are shaping the future of AI and software validation, ensuring compliance and innovation go hand in hand.
BIO:
Validation for software and information systems
20 years of experience in the industry
I’ve been working in the RS NESS group for about two years in the validation team
12:00 - 12:20
Cyber Security – Lessons Learned from FDA Submissions
Moshe Klaiman
CEO & CTO
Matrix Medika
At Medika, we highly value and appreciate all cybersecurity guidelines and standards (from NIST to the FDA). But as the joke goes - what really matters is practice. Therefore, we will present key and fundamental insights from the FDA regarding actual cybersecurity submissions, what we have learned directly from them, and what we have gathered about the FDA's sentiment on the subject.
BIO:
With over 20 years of experience in development, management and R&D in the healthcare industry, Moshe founded Medika (now part of Matrix) to deliver high-end projects, systems, and domain expertise to cutting-edge medical device and digital healthcare companies.​ Under Moshe’s leadership, Medika has made a name for itself by taking on the regulation, cybersecurity, and development challenges unique to the industry.
Erez Metula
CEO
AppSec Labs
12:20 - 12:40
Cybersecurity in Medical Products and Services – What Penetration Testing Means?
In a world where medical technology is at the forefront of innovation, the integration of advanced medical devices with computerized systems requires addressing unique cybersecurity challenges. Medical products, such as wearable medical devices, remote monitoring systems, and computerized surgical equipment, are attractive targets for attackers due to the sensitive information they process and their potential to impact human lives.
In this talk, we will discuss the critical importance of conducting security testing for medical products, focusing on specialized methodologies for identifying vulnerabilities, managing risks, and complying with strict regulations such as HIPAA and FDA requirements. We will review real-world examples of breaches discovered in medical systems, analyze the root causes, and present advanced methods for preventing such incidents.
Participants will gain a better understanding of what it means for medical devices to be resilient to cyberattacks, the concept of penetration testing, and how to address the unique challenges of securing medical products.
BIO:
Erez Metula, an application security expert, is also the founder and CEO of AppSec Labs, a leading company in the field of application security.
He is the author of the book "Managed Code Rootkits", and holds an MSc in computer science.
Erez has extensive hands-on experience performing security assessments, code reviews and secure development trainings for worldwide organizations, and had previously talked at international security conferences such as BlackHat, Defcon, OWASP, RSA, SOURCE, CanSecWest and more. Erez is a frequent trainer at BlackHat, providing cutting edge security training for developers and penetration testers.
Erez had helped companies from all sizes, from startups to fortune 500 organizations.
Erez focuses on advanced application security topics and has performed extensive ground breaking research on web application, mobile application and IoT security.
Dina Sifri
Founder and CEO
MedDev Soft
12:40 - 13:00
Beyond the Checklist - Why Regulatory Submission of Medical Device Software Requires More Than You Expected
Beyond the Checklist : Why Regulatory Submission of Medical Device Software Requires More Than Expected
The regulatory submission process for medical device software demands far more than checking boxes. In this session, we'll explore how compliance with global regulatory standards requires deep understanding of classification systems, risk management, cybersecurity, and quality processes. Together, we'll examine the critical aspects of regulatory submissions across FDA, EU MDR, and international regulations.
Learn how companies must integrate robust compliance strategies, development processes, cybersecurity, and usability engineering to ensure regulatory success. We'll discuss:
• Strategic approaches to classification and regulatory pathways
• Essential standards for risk management and software development
• Implementation requirements for cybersecurity and AI/ML integration
• Critical factors in human engineering and usability validation
• Post-market surveillance and compliance maintenance strategies
This session provides practical insights for medical device manufacturers, regulatory professionals, and software developers. Discover how early preparation and following best practices can streamline your approval process and ensure long-term market success.
BIO:
Dina Sifri is a seasoned expert in medical devices and digital health software development and regulation. With decades of experience, she has guided hundreds of companies through the nuances of software, cybersecurity, and regulatory compliance. Dina has been instrumental in hundreds of medical product submissions and has extensive experience in implementing and auditing software standards, QMS, and ISMS systems. As an Israeli representative in ISO forums and a member of eight committees in AAMI, her contributions span across cyber, software, usability, software risks, information security, and AI/ML fields.
13:00 - 14:00 : Lunch, Exhibition Visit
14:00 - 14:20
FIH Fast Track
In today's challenging environment, fast clinical evidence is priceless. Achieving First-In-Human (FIH) trials has become a key milestone for many companies, but this often conflicts with the extensive regulatory requirements imposed by various authorities. While we aim to maintain a comprehensive design control process that oversees design, production, risk, and testing activities, companies focused on FIH or pilot studies often struggle to meet all the requirements of MDR, CFR 820 or ISO 13485. To address this, we have developed a streamlined QMS tailored to meet expectations for FIH trials efficiently.
BIO:
Liat has more than 20 years of experience in regulatory affairs, clinical management, and quality assurance for medical devices. Prior to founding LDP and Duet Medical, two consultancy agencies, she served many years as the regulatory and clinical manager in start-up companies, mostly in the field of Class III cardiovascular devices, like BBalloon and ByPass Maakafim.
Her part in start-up companies allowed her to acquire a deep understanding of design and manufacturing constraints and limitations, risk management, and usability processes.
Liat Diamant Porat
CEO
LDP Consulting
Adv. Limor Tarsi-Chen
Founder & Owner
LTC Law Office
14:20 - 14:40
Advertising Medical Devices in the Age of Innovation: Navigating Regulatory Challenges and Opportunities
In this lecture, we will explore the evolving landscape of advertising medical devices in an era of rapid innovation. As technology continues to advance, the regulatory frameworks surrounding the promotion and marketing of medical devices face new challenges and opportunities. We will examine the intersection of regulatory requirements, advertising practices, and emerging trends, focusing on the importance of compliance with local and international regulations, including those pertaining to claims, product positioning, and digital platforms.
BIO: Adv. Limor Tarsi-Chen is the founder of the boutique law firm, Limor Tarsi-Chen Office, which specializes in healthcare and pharmaceutical systems. Combining her legal expertise with a strong scientific background, she provides strategic guidance to companies navigating complex regulatory landscapes. As a seasoned lecturer, Limor imparts her extensive knowledge and practical insights to industry professionals, equipping them to address regulatory challenges and thrive in the dynamic healthcare sector.
Becky Moses
Human Factors Practice Leader
Core Human Factors
14:40 - 15:00
Applying Human Factors to Make Safe and Effective Medical Devices and Meet US and EU Regulatory Requirements
What human factors processes do FDA and notified bodies require?
What is the difference between a human factors study and a clinical trial?
How do I know if I need a full human factors validation/summative study?
Tips for saving costs in your human factors program
BIO:
Becky specializes in making medical devices safe and effective from a usability perspective. She leads usability research to drive product design and comply with FDA and international standards. She has assisted clients worldwide​ with their human factors planning, ​resulting in successful approvals and clearances of medical devices and combination products. Becky is a Human Factors Practice Leader at Core Human Factors, a US based human factors and usability consulting firm. She is located in Israel, ​with a focus on the Europe/Middle East/Asia market and has over 13 years of experience as a human factors consultant.
Shay Levav
VP Quality Assurance, Regulatory Affairs and Clinical Application
IceCure Medical
15:00 - 15:20
IceCure Journey for Marketing Authorization - ProSense™ Cryoablation System, Treating Women with Early-Stage, Low-Risk Breast Cancer
De Novo application submitted by IceCure Medical for ProSense™ Cryoablation System, seeking an expansion of indications for the FDA-cleared ProSense™ Cryoablation System to include treatment of early stage, low-risk breast cancer. As part of the process given the public health importance of IceCure request for Breast cancer indication, the U.S. FDA has decided to convene public advisory panel. The U.S. FDA is using Medical Devices Advisory Committee panels to obtain independent expert advice on scientific, technical, and policy matters.
Data from the company’s multicenter ICE3 clinical study that supports the safety and effectiveness of the ProSense™ Cryoablation System for treatment of women with early stage, low risk breast cancer was submitted to the FDA and is the basis for the advisory panel public discussion and for the FDA final decision. The data was submitted together with comparisons to standard of care, BiMO Audits results and additional information. The panel members voted on questions related to safety, efficacy, and benefits/risks and gave their recommendation to the FDA.
BIO:
Vast experience of nearly 25 years in Quality, Regulatory, Processes Improvements and leading cross organization projects
VP Quality Assurance, Regulatory Affairs and Clinical Application 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 managing positions at Carestream Health (formerly Orex Computed Radiography)
Israel A. Citron MBA, MSc.
VP Regulatory Affairs and Quality Assurance
Pulsenmore
15:20 - 15:40
Can ChatGPT Assist with Risk Management? A Guide to Conducting Risk Management for Medical Devices Incorporating ML/AI
Machine learning and AI are taking part in many medical devices (MD) and in software applications as medical device SaMD.
How to conduct a risk management for a medical device that incorporates AI/ML is a question regulator are working on to provide a concise framework for.
This short lecture will review the current activities in the international standardization organizations (ISO, AAMI) and the issues we are facing with some tips and tricks
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.