Student Login |


Friday, June 18, 2021
Home » EU Medical Device Regulation (EU MDR) - Chapter 3: Identification, Traceability and Registration of Devices

EU Medical Device Regulation (EU MDR) - Chapter 3: Identification, Traceability and Registration of Devices (ELM-319)

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) - Chapter 3: Identification, Traceability and Registration of Devices
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 ReviewsWelcome to EU MDR 2017/745 - Module 3 -Chapter III - Identification and traceability of devices, Registration of Devices and of Economic Operators, Summary of Safety and Clinical Performance, European Database on Medical Devices. There are 10 articles in this chapter: articles 25 through to 34 inclusive. Articles 25, 26, 28 and 34 are comparatively short so naturally we shall spend the bulk of the time in this module examining the other six articles.
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) - Chapter 3: Identification, Traceability and Registration of Devices 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
Previous Module
Module Introduction
Learning Objectives for this Module
Medical Devices

Article 26 - Medical Devices Nomenclature
Article 26 - Medical Devices Nomenclature

Article 33 - European Database
Article 33 - European Database

Article 34 - Functionality of EUDAMED
Identification within the Supply Chain
Registration

Article 29 - Registration of Devices
Article 29 - Registration of Devices

Article 30 - Electronic System for Registration of Economic Operators
Article 30 - Electronic System for Registration of Economic Operators

Article 31 - Registration of Manufacturers, Authorized Representatives and Importers
Summary of Safety and Clinical Performance
Unique Device Identification (UDI)

Article 27 - Unique Device Identification System
Article 27 - Unique Device Identification System

Article 28 - Unique Device Identification Database
Article 28 - Unique Device Identification Database

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):