From MDD to EU MDR

תאריך: 29, 30 מאי 2018
מיקום הקורס: כפר המכביה, רמת גן
מידע כללי
משך הפעילות: 2 ימי לימודים מלאים
שעות:  09:00-17:00
עלות: 4,700 ש"ח + מע"מ
נקודות זכות: 2
מק''ט: 18878
שפת הקורס: אנגלית
על הקורס

The aim of this course is to inform the participants about the impact of the new European Medical Device Regulation that has entered into force per May 26, 2017. During the training, the new requirements will be discussed in detail and where possible will provide answers on how to implement the changes.

The first day will focus on the revised scope of the Regulation compared to the Directive, the timelines of the transitional three years (and beyond), identify the requirements for the Economic Operators as defined by the EU MDR (including Person Responsible for Regulatory Compliance) and discusses impacts for Health institutes in the European Union.

On the second day, the revised classification rules and conformity assessment routes are discussed and compared to the current requirements, resulting in a clear overview of actions to be taken regarding compliance with revised QMS, Technical dossier and PMS requirements.

קהל היעד

This course will be extremely useful for the persons working in regulatory and quality assurance departments, and equally important for project managers or CTO’s involved in development of new medical devices. Last but not least, as CEO of a medical device company, you will obtain a clear insight in the new EU requirements and the impact it will have on your business case or company.

From MDD to EU MDR
התועלת שתופק

At the end of the seminar, you will be able to draft your company’s action plan, enabling working towards EU MDR compliance throughout the lifecycle of a medical device.

השאר פרטים למידע נוסף
  • שם מלא
  • דוא''ל
  • טלפון
  • הערות
  • שלח
תכני הקורס

Day 1:

  • Introduction, including timelines
  • Scope of the MDR (Article 1), new/revised important definitions (Article 2) and Eudamed
  • Economic Operators – their roles, rights and responsibilities
  • Impact for Health Institutes in the EU + Custom made devices

Day 2:

  • Classification and Conformity Assessment routes
  • QMS requirements – including comparison to ISO 13485:2016
  • Annex I: General Safety and Performance Requirements
  • Annex II: Technical Documentation requirements
  • Post Market Surveillance, including vigilance, FSCA.
אודות המרצה

Mr. Robert Van Boxtel

Robert van Boxtel has over 20 years of experience in the medical device industry, working first in medical device production sites in the Netherlands and USA, and later on worked for the Dutch Notified Body KEMA Quality (now Dekra Certification).
לפרטים נוספים אנא לחצו כאן

קורסים נוספים באותה קטגוריה
קורסים נוספים של אותו המרצה
לומדים אצלנו