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Mon, 27 May

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Virtual Event

Medical Device Design Controls For Engineers - Online Live Training (Hebrew)

Design Engineers and Product/Project Managers are welcome to join a basic training on Medical Device Design Controls and their implementation according to ISO-13485 and applicable regulations such as US FDA QSR (21 CFR 820). What each Design Controls element requires? Join me for half-a-day training

Medical Device Design Controls For Engineers - Online Live Training (Hebrew)
Medical Device Design Controls For Engineers - Online Live Training (Hebrew)

Time & Location

27 May 2024, 9:30 am – 1:00 pm GMT+3

Virtual Event

About the event

Design Engineers and Product/Project Managers are welcome to join a basic training on Medical Device Design Controls and their implementation according to ISO-13485 and applicable regulations such as US FDA QSR (21 CFR 820). What are the design controls and what each element requires? Join me for half-a-day training on this important topic where you can gain the knowledge and ask questions as much as you like!

Agenda:

09:30-11:30

  • Design Controls Overview
  • Design and Development Planning
  • Design Input
  • Exercise - Requirements
  • Risk Management
  • Design Output
  • Design Review

11:30-11:45    Break

11:45-12:45

  • Design Verification
  • Design Validation
  • Exercise – Design Verification Vs. Validation
  • Design Transfer
  • Design Changes
  • Design History File

12:45-13:00  Summary and Q&A session

Intended for: Design Engineers, Product/Project Managers.

About the trainer:

Helit Dovrin - Executive Consultant, Coach, Auditor and Lecturer worked for more than 25 years as Quality and Regulatory Senior Leader at the world leading medical device companies such as: Philips Healthcare, GE Healthcare, Align Technology and Biosense Webster part of Johnson & Johnson.

Helit gained experience & expertise in all areas of the Quality Management System and Regulatory Affairs including FDA & Notified Body Inspection Management, ISO-13485, EUMDR & MDSAP Compliance Audits, and Quality & Safety escalations.

Tickets

  • General Ticket

    ₪400.00

Total

₪0.00

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