Quality and Regulation Course for the Medical Device Industry
Regulatory
Quality
Starts at: 09:30
Duration: 5 Meetings
Language: Hebrew
The focus of this course is the practical application of quality requirements and the regulatory tools and pathways available through the US FDA and the EU. During the course, real-world examples and exercises will be used to help you understand the requirements and how to comply with them
effectively.
The US and the EU are the world’s leading medical device markets, with a unique regulatory
framework.
Navigating both the quality requirements and the regulatory landscapes of the EU and US is an essential skill for anyone interested in working in the medical device field or looking to bring a device to market in the EU and the US.
Course dates:
5.2.25- Medical Device Quality Requirements Course
12.2.25 - Medical Device Quality Requirements Course
19.2.25-Medical Device Regulation- USA
26.2.25- Medical Device Regulation- EU (MDR)
5.3.25- Risk Management
Location; Haifa Matam
Course Hours - 09:30-15:30
Price - 6,000 NIS + VAT
About Dana Tirosh B.A.
Regulatory and Quality expert and a certified lead auditor (BSI Certified Lead Auditor - ISO 13485:2016 IRCA Certified) Experienced in establishing, implementing and maintaining a QMS, well familiar with international standards and regulations, audit management, project oversight and Global Regulatory Submissions. Successfully participated in many ISO 13485, EU and MDSAP Audits as the lead point of contact. Dana is...About Ella Sheiman, D.V.M
Dr. Ella Sheiman graduated her bachelor's degree in life sciences from Ben Gurion University of the Negev with honors and completed her Doctor of Veterinary Medicine degree at the Koret School of Veterinary Medicine, in the Hebrew University of Jerusalem. As a veterinary doctor, she worked at the Veterinary Hospital in Beit Dagan and was extensively exposed to medical devices...About Sivan Luder, PhD
Dr. Sivan Luder is a Regulatory, Clinical, and Quality Expert with a PhD in Molecular Biology and over 10 years of experience across various industries, with a strong focus on the medical device sector. Possesses a deep scientific background and extensive experience in leading the development and implementation of medical devices from concept to commercialization, managing regulatory projects, and preparing...
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Comments
The focus of this course is the practical application of quality requirements and the regulatory tools and pathways available through the US FDA and the EU. During the course, real-world examples and exercises will be used to help you understand the requirements and how to comply with them
effectively.
The US and the EU are the world’s leading medical device markets, with a unique regulatory
framework.
Navigating both the quality requirements and the regulatory landscapes of the EU and US is an essential skill for anyone interested in working in the medical device field or looking to bring a device to market in the EU and the US.