Medical Device Design Controls - Online Live Training (Hebrew)

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.

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: 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.