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Home » EU Medical Device Regulation (EU MDR) - Introduction

EU Medical Device Regulation (EU MDR) - Introduction (ELM-316)

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) - Introduction
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 ReviewsThis module is an introductory module to explain how, why and when the new regulations have come into force, what they consist of and some of the new and strengthened features. We will look at some of the historical events that have occurred over a period of decades and their consequences and we will be able to see the triggers for changes in legislation and understand what brought these changes about. This module includes a high-level overview of the contents of EU MDR 2017/745, some of the new features, the timelines for compliance and we'll take a look at how the new MDRs compare to MDD.
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) - Introduction 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
Program Introduction
Program Contents
Module Introduction
Learning Objectives
Introduction to EU MDR

History of EU MDR 2017/745
Key Events and Timeline
1901 - Jim the Horse Tetanus Scandal
1906 - Pure Food and Drug Act
1937 - Elixir Sulfanilamide Mass Poisoning
1957 - Thalidomide
1964 - The Yellow Card Scheme
1971 - The Dalkon Shield
1990 - FDA Device Recall Report
1996 - ISO 13485 Medical Devices - QMS
1997 - Food and Drug Administration Modernization Act
2009 - Poly Implant Prothèse (PIP) Breast Implants
2010 - DePuy Hip Replacement Recall
2012 - Stryker Modular-Neck Hip Stem Implants Recall
2012 - Batteries of Pacemakers and Implantable Defibrillators
2019 - Medtronic's Product Recall of Implanted Cardiac Pacemakers
2019 - Injectable Cosmetic Treatments

A Regulatory Evolution
A Regulatory Evolution
The Regulation
Chapters and Articles
Annexes
Timelines
What does this mean?
MDD vs MDR
Summary

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.

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