Quality and Regulation Course for the Medical Device Industry
Sep 2, 2024
By Dana Tirosh B.A. & Gadiel Rothe M.Sc & Ella Sheiman, D.V.M & Marina Lebel, B.Sc., CQE
Cycle 12
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:
2.9.24
9.9.24
16.9.24
23.9.24
30.9.2
Course Hours - 09:30-15:30
Course Location - Building 22 Matam Park, Haifa
Price - 6,000 NIS + VAT
Registration Link: https://gstudy.ravpage.co.il/QA_RA_LANDING
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 Gadiel Rothe M.Sc
Regulatory and Quality specialist. Experienced in establishing, implementing and maintaining a QMS (ISO 13485, ISO 9001 and ISO 22716 standards), well familiar with international standards and regulations (EU MDR 2017:745, MDSAP) and Global Regulatory Submissions. Successfully participated in EU and MDSAP Audits.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 Marina Lebel, B.Sc., CQE
Marina Lebel holds a B.Sc in Chemical engineering from the Technion in Haifa and a CQE certification from the American Society for Quality ASQ. Marina has over 20 years of experience in quality management, quality lectures, and quality consultancy in various industrial fields, including Aerospace, Military, Medical devices, and Testing Laboratories. Marina led and managed the establishment of quality infrastructures...
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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.