Student Login |


Friday, June 18, 2021
Home » EU Medical Device Regulation (EU MDR) - Chapters 1 to 5

EU Medical Device Regulation (EU MDR) - Chapters 1 to 5 (ELM-327)

Certification Training
Method of Training: Online / Self-paced eLearning.
Credits: 0.1 CPD Credits.
Duration: ~60 minutes.
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
CPD Accredited TrainingCatalog: Medical Device Regulatory Affairs.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.

PRICE: USD $199.00

Document a dedication to your career and job performance by earning a training certification from Biopharma Institute.

Biopharma Institute LogoTraining Program: EU Medical Device Regulation (EU MDR) - Chapters 1 to 5
Training Provided By: Biopharma Institute
Website: https://www.biopharmainstitute.com

Schedule: Self-paced. Immediate access to training materials upon ordering.

Description: Online training with immediate access upon enrollment. Biopharma Institute ReviewsThe objective of this course is to provide you with an overview of the EU MDR 2017/745. This overview will guide you through the following the background of the EU MDR, why it was introduced, the EU MDR structure and timeline, the main differences between MDD and MDR, an overview of each chapter and some of the key challenges facing organizations due to its introduction. It is designed to provide the student with a high-level comprehension of the regulation and what it means for organizations in today's world of medical device manufacture.
Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment with passing score within a 90-day period of time (180 days for Professional Certification Programs). Certificate is accessible in PDF format immediately after satisfying requirements.


EU Medical Device Regulation (EU MDR) - Chapters 1 to 5 course is included in the following Professional Certification Programs:



EU Medical Device Regulation (EU MDR) for Professionals: Review the individual courses included in this program (see below) for program descriptions and outlines. This online training program includes immediate access after enrollment. Username, password, and instru ... Learn more

COURSE OUTLINE:


Introduction
Overview Introduction
Learning Objectives for this Overview
The Background of the EU MDR 2017/745
1901 - Jim the Horse Tetanus Scandal
1959 - Primodos
1996 - ISO 13485 Medical Devices -- Quality Management Systems
2018 - Vaginal Mesh Implants
A Regulatory Evolution
Introduction to EU MDR
The Regulation
Chapters and Articles
Annexes
The EU MDR Timeline
What this means
MDD vs MDR
Chapters I to V

Chapter I
In Scope
Out of Scope
Definitions

Chapter II
Placing on the market and putting into service
Claims
Common Specifications
General obligations of Manufacturers
Authorized Representative
General obligations of Importers
General obligations of Distributors
Person Responsible for Regulatory Compliance (PRRC)

Chapter III
Medical Devices Nomenclature
European Database
Registration of Devices
Unique Device Identification System

Chapter IV
Authorities Responsible for Notified Bodies
Requirements Relating to Notified Bodies
Assessment of Application

Chapter V
Classification of Devices
Assessment of Conformity
Certificate of Sale

Conclusion


Final Assessment


Certification

COURSE OBJECTIVES:


Skill Level:
Intermediate

This training program has been developed to train employees with Intermediate Knowledge of The European Union Medical Device Regulation (EU MDR).

Online Training: The Benefits of Remote Learning & eLearning

  • Immediate access to training: Instructions, username, password, and receipt of payment are emailed instantly upon online enrollment.
  • Optimized for learning: Courses include voice-overs, easy navigation, progress checks, and high-quality animations to increase retention of subject matter.
  • Self-paced courses: 24/7 access to individual courses for 90 days, and for professional certification programs for 180 days.
  • Flexible final assessments: Assessment testing include multiple-choice questions and can be taken repeatedly until a passing score is achieved.
  • Direct access to certificates: Certificate of completion is instantly available once course requirements have been fulfilled.
  • Verification of training: Certificates can be verified online, and digital badges are issued for all Professional Certification programs.
  • Tuition reimbursement: Some employers may reimburse for training expenses; check on your company's training reimbursement policy.
  • Financial assistance: Payment plans are available to those who qualify. These are offered when paying electronic invoices, online. You must first request an invoice to be considered. Alternatively, purchasing individual courses one at a time is also an option.
  • Purchase orders (POs) accepted: If a PO is required by your company, request an invoice to start the procurement process.
  • Corporate LMS compatibility: All courses are SCORM compliant and can be delivered from most corporate Learning Management Systems.
  • Secure and safe access: Website and LMS provide an encrypted connection with firewall protection and daily scans for optimal level of security and performance.
  • Career advancement: Professional certifications help demonstrate your interest and dedication to job performance, and may be helpful for those seeking a new career or transitioning to different positions within their organization.

Contact Us:

For more information on the Biopharma Institute's training programs, or to suggest a course, please complete the form located below. Alternatively, you may call toll free in the US: (888) 4-BIO-LRN, international callers can dial (201) 301-8370.

Information Request / Suggest a Course Form:

NAME:
COMPANY:
ADDRESS:
CITY:
STATE:
ZIP CODE:
COUNTRY:
PHONE:
EMAIL:
 
Enter the number from the image above
COMMENTS or Suggest a course:
(For pricing information, please provide us with as much detail as possible about your training project):