Quality and Regulation in Medical Devices
Gstudy > Courses and seminars > Quality and Regulation in Medical Devices
Nov 2, 2022
By Marina Lebel, B.Sc., CQE & Ossie Milanov, B.A.
8.0
Quality
Regulatory
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...
Register
Thank you for registering to the course!
We will contact you soon in order to complete the registration procces.
In the meantime, the course details have been emailed to you.
Comments
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!
For further information please contact Lital at Lital@gsap.co.il