MEDICAL DEVICE REGULATION (MDR 2017/745)
  • Medical Device - Quality Management system

  • Start in: 12.06.21

  • End In: 10.06.21

MEDICAL DEVICE REGULATION (MDR 2017/745)

0000 EGP

  • Overview
  • Lead Tutor

MEDICAL DEVICE REGULATION (MDR 2017/745) TRAINING COURSE

overview to align your organization with the new requirements of the MDR


Course Details

 
This course is designed to provide you with an understanding of ISO 14971:2019 and the impact it has on the design, development, manufacturing, and lifecycle of medical devices. It will also provide medical device manufacturers with knowledge of how ISO 14971:2019 links with the ISO 13485:2016 standard and the MDR 2017/745. Practical activities throughout the day will give you the opportunity to apply your skills, implementing risk management activities so that these can be embedded within the organization on completion of the course.


 

 

Learning Objectives

Upon Completion of this training, you will be able to:
  • Define risk management terminology
  • Explain how risk management relates to the product lifecycle
  • Outline the stages of the risk management process
  • Define the key deliverables of the risk management process
  • Apply risk management principles within your organization
  • Identify the links between ISO 14971:2019, ISO 13485:2016, MDR 2017/745 and the IVDR 2017/746
 

WHO WILL BENEFIT?

  • Newcomers in the medical device industry
  • Expert and executive personnel to update their knowledge
  • Personnel in charge of regulatory affairs
  • Personnel in quality management
  • Consultants in the medical device industry
This course is intended for auditors of medical device manufacturers and anyone in the medical device industry who wants to gain an understanding of IVDR.

Learners attending the virtual training option require hardware, internet connection and audio connection for the full duration of the course. 


 

COURSE AGENDA

- Contents and Fundamentals of the Medical Device Regulation (MDR)
- Classification/Reclassification of Products
- Non-Medical Products within the Scope of the Medical Device Regulation (MDR)
- Common Technical Specifications
- New Basic Requirements
- Content Requirements for Technical Documentation
- Post Market Surveillance
- Scrutiny Procedure
- Validity of Conformity Assessment and  Certification, Transition Periods
- Requirements for Different Actors, e. g.:
  1. Manufacturers
  2. Importers
  3. EU Representatives
- Distributors and Service Partners
- Role of Contact Person for Regulatory Compliance
- Eudamed Database
- UDI (Unique Device Identification)


Course Venue/Mode

Courses are held through the ABC Academy halls / Online 


Duration

(16 Hours)  / 2 Days consecutively

Dr. Mohamed Moustfa

Dr. Mohamed Moustfa

Lead Auditor QMS - EMS - OHS - FSMS - MD

DR. MOHAMED is backed with more than 25 Years of Experience , his career started since his graduation in 1996 in the filed of Food and Agriculture as an agronomist , management system consultant , instructor and ...

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