סמינר איכות בפיתוח מיכשור רפואי והרגולציה האירופאית
Wed, 06 Sept
|Caesarea, Regus
Join our training session where experts will discuss the criticality of design controls and their implementation in accordance with ISO-13485 and EU MDR. Discover how these controls play a vital role in compliance of technical documentation and obtaining CE mark in Europe. Seats are limited!
Time & Location
06 Sept 2023, 9:30 am – 1:00 pm GMT+3
Caesarea, Regus, HaEshel St 1, Building B, ground floor, Caesarea, 37000, Israel
About the event
Design controls and their implementation according to ISO-13485 and the new regulation in Europe for medical devices (EU MDR) are critical for the compliance of the technical documentation and obtaining the CE mark for sale in Europe. What are the design controls and how are they reflected in the European regulation? Experts in the field will discuss this in a half-a-day seminar.
Agenda:
09:30-10:00 Gathering and light refreshments
10:00-11:15 Design Controls requirements in medical device development according to ISO-13485:
Content of the Design History File (DHF), including all elements required by standard.
11:15-11:30 Break
Tickets
General Ticket
₪300.00
Sale ended