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Sun, 17 Mar


Virtual Event

Medical Device Design Controls - Online Live Training (Hebrew)

Join our on-line zoom training session where we will discuss the criticality of design controls and their implementation in accordance with ISO-13485 and applicable regulations. Discover how these controls play a vital role in product compliance!

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

Time & Location

17 Mar 2024, 9:30 am – 1:00 pm GMT+2

Virtual Event

About the event

Design controls and their implementation according to ISO-13485 and applicable regulations such as US FDA QSR (21 CFR 820) and EU MDR are critical for the compliance of product submissions worldwide . What are the design controls and what each element requires? Join me for half-a-day training on this improtant topic.



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

11:30-11:45    Break


  • 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: Employees and managers of medical device companies: CEOs, quality and regulatory managers, design and product managers, engineers.

About the trainer:

Helit Dovrin - Executive Consultant, Auditor, Lecturer and Coacher 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.


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