Digital Health: From Idea to Execution – Navigating Development, Quality, and Regulatory Challenges
Sunday | 06.04.2025
14:30 Israel Time
Join our exclusive webinar to gain practical, experience-based insights from Gsap and Matrix Medika industry experts.
Gsap by Novolog is an international consulting firm for healthcare companies, providing end to end services throughout the life cycle of medical products.
Gsap aspires to enhance the development and maturation of healthcare companies and to empower them to achieve significant therapeutic solutions for patients worldwide.
Matrix Medika is a leading company in Israel specializing in development, engineering, and regulation in the fields of medical devices and digital healthcare, with 20 years of experience and over 300 projects. The company excels in software development for medical devices, applications, and cloud systems, as well as in the design and development of interfaces for medical systems (HL7, FHIR, DICOM). We have strong expertise in regulatory compliance, including HIPAA, GDPR, and cybersecurity. Matrix Medika leads projects in telemedicine, remote patient monitoring, and provides cloud solutions in partnership with Amazon, Microsoft, and Google.
WEBINAR'S PRIMARY TOPICS
Introduction
Ella Sheiman (Gsap)-Lessons Learned from Digital Health Product Submission to the EU and US
Speakers
Dr. Ella Sheiman
An experienced regulatory affairs professional in the medical devices field. She brings with her a wealth of knowledge from leading roles in Medical Device Regulation, Quality, and Clinical Affairs. She has a proven track record of leading teams, obtaining regulatory licenses, and establishing quality systems. With a medical degree in Veterinary Medicine from The Koret School of Veterinary Medicine and advanced training in worldwide regulatory requirements, she specializes in software-contained medical devices, digital health, AI-related regulations, and In-Vitro Diagnostic products.
Margalit Anukov
Quality Assurance and Regulatory Affairs (QA/RA) professional with over four years of leadership experience as VP QA/RA at Matrix Medika, managing company-wide QA/RA and information security operations. Provides consultancy in software QA/RA, regulatory submissions (FDA/CE), and privacy and security compliance under HIPAA, GDPR, and global cybersecurity guidelines. Holds a B.Sc. in Biotechnology from Ben-Gurion University of the Negev.
Brings a strong background in the pharmaceutical and medical device industries, with expertise in ISO 13485, ISO 14971, ISO 62304, FDA QSR, MDD/MDR, IVDD/IVDR, TGA (Australia), and Health Canada regulations.
WHAT'S IN IT FOR YOU?
By participating in this webinar, you'll gain actionable insights that will:
- Streamline your digital health product development process
- Help you avoid common regulatory pitfalls
- Reduce costly delays in product submissions
- Increase your chances of successful market approval in the EU and US
Additionally, our interactive Q&A session will provide you with the opportunity to address your specific challenges and receive personalized advice from industry experts.
Don’t miss this chance to transform your ideas into execution-ready strategies that can propel your product to market success!
REGISTER RIGHT NOW
For registrants who are not from Israel, there is no need to fill in the phone number.
For more information or questions,
contact us - Gstudy@gsap.co.il
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