Quality and Regulation in Medical Devices

Medical devices industry Gsap
Gstudy > Courses and seminars > Quality and Regulation in Medical Devices

Nov 2, 2022

By Marina Lebel, B.Sc., CQE & Ossie Milanov, B.A.




Location: Frontal

Starts at: 09:30

Duration: 40 academic hours

Language: Hebrew

Course syllabus:

A practical approach to medical device regulatory and quality aspects

Day 1
Medical Devices Quality System Requirements
Day 2
Design Controls & Monitoring and Feedback
Day 3
Medical Device Regulations - Europe
Day 4
Medical Device Regulations – USA
Day 5
Risk management – Making it work for you !
  • 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...
  • About Ossie Milanov, B.A.

    Ossie Milanov is a regulatory and quality expert. She has worked with many start up medical device companies over the years.  She has experience in establishing, implementing and maintaining a QMS; in particular effective and compliant Risk Management and Post Market Surveillance. Ossie has experience in preparing Regulatory Strategies and submissions for the FDA, EU and WHO. She has successfully participated in...


The course is intended for all those involved in the development and production of medical devices, with at least one year of experience in the field of quality management.

Gsap invites its customers to register new candidates/ employees for training in the course in order to establish professional knowledge for further activity in their company.  At the end of the course, a certificate will be distributed to the participants!

  • Location: Matam Haifa
  • Course Fee : 5,000 NIS + Tax
  • **The course will be held  according to the procedures of the Ministry of Health during the Corona period, in a large space that allows for social distance and observance of the rules

For further information please contact Lital at Lital@gsap.co.il


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