Student Login |


Friday, June 18, 2021
Home » EU Medical Device Regulation (EU MDR) - Chapter I: Scope and Definitions

EU Medical Device Regulation (EU MDR) - Chapter I: Scope and Definitions (ELM-317)

Certification Training
Method of Training: Online / Self-paced eLearning.
Credits: 0.1 CPD Credits.
Duration: ~45 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 I: Scope and Definitions
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 ReviewsThere are only four articles in this chapter. Articles 3 and 4 are comparatively short so naturally we shall spend the bulk of the time in this module examining Articles 1 and 2. In this module, we will cover Article 1 - the Subject Matter and Scope, which sets out what this regulation applies to as well as what this regulation does NOT apply to. We shall also examine where a decision is required to determine which set of regulations (other than EU MDR 2017/745) a product is governed by.
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 I: Scope and Definitions 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

Article 1
Article 1 - Subject Matter and Scope
In Scope
Out of Scope
It Depends

Article 2
Article 2 - Definitions
Marketed in the European Union
Medical Devices
Custom-Made Device
Active Device
Implantable Device
Invasive Device
Generic Device Group
Single-Use Device
Procedure Pack and System
Conformity Assessment and CE marking
Intended Purpose, Label and Instructions for Use (IFU)
Unique Device Identifier' ('UDI')
Risk Management Definitions
Clinical Definitions
Economic Operators
Post-Market Surveillance and Market Surveillance
Refurbishing and Reprocessing
Commonly Understood Definitions

Articles 3 and 4
Overview
Article 3 - Amendment of Certain Definitions
Article 4 - Regulatory Status of Products

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):