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Tuesday, June 27, 2017
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Medical Device Regulatory Affairs: Global (MDG1)

Certification Training Duration: 1.5 hours (the average time to complete the training program, including final assessments).
Credits Hours: 1
Demonstration: Demo an online course.

Certificate: View sample certificate.

PRICE: USD $149.00

dinaris.org LogoTraining Program: Medical Device Regulatory Affairs: Global
Training Provided By: dinaris.org
Website: http://dinaris.org

Availability: Immediately available upon ordering.

Description: Online training with immediate access upon enrollment.

This is an online program offering training with immediate access upon enrollment. Medical devices are globally regulated by a series of regulations and rules designed to produce an effective and safe device. This online course guides you through an overview of regulations that apply to global medical devices. This course is also found in the Global Medical Device Regulatory Affairs Professional Certification Program. The objectives of this course are to outline the steps needed to obtain a manufacturer license, outline the steps needed to ensure that a device meets registration requirements, identify the regulatory requirements during the lifecycle of a product, to identify the major regulatory agencies, recognize the classification system of medical devices, and will define the term ‘medical devices’.

Once all course requirements have been satisfied, a Certificate of Completion is immediately available. Course takers can take the final assessment any number of times, as needed, in order to achieve a passing grade.

Benefits of Getting Certified at dinaris.org

By employing advanced e-learning training techniques, and coupling them with automated tracking systems, the dinaris.org is helping companies, both abroad and within the US, by maintaining training records, teaching their employees, and improving their overall service quality. We can assist you, your colleagues, or your employees to succeed and advance corporate and career objectives.

Have Questions?

Should you have any particular question about this course, you can call us at (888) 111-1111 or send us an email at for more information.


Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment with >80% passing grade within a 90 day period of time (180 days for Professional Certification Programs). Certificate is accessible in PDF format immediately after satisfying requirements.

Online Training Programs Include:

  • Immediate access to training: Instructions, password, and username are emailed following order
  • 90 days of 24/7 access to individual training programs / 180 days for Professional Certification Program
  • Programs include voice-overs, easy navigation, progress checks, and high-quality animations
  • Course notes (in PDF) and/or references available with select training programs
  • Online final assessment with multiple-choice questions can be taken an unlimited number of times, until passing grade is achieved
  • A Certificate of Completion is immediately available once course requirements have been satisfied


The Medical Device Regulatory Affairs: Global Course is Found in the Following Professional Certification Program(s):


Global Medical Device Regulatory Affairs Professional Certification Program: This Global Medical Device Regulatory Affairs Professional Certification Program is an online program which guides the student through a global medical device regulations overview. It discusses how ISO13485:200 … Learn more

COURSE OUTLINE:


INTRODUCTION
1. Welcome
2. Introduction
3. Assessment

OVERVIEW
4. Introduction
5. Overview
6. Regulatory Bodies and Important Agencies
7. Definitions
8. Classification of Medical Devices
9. Factors in Classification
10. Registration
11. Medical Device Life Cycle
12. Review

CONCLUSION
13. Summary

COURSE OBJECTIVES:


Define the term medical devices.
Describe the medical device classification system.
Recognize that medical device classification systems are based on risk.
Identify the major regulatory agencies.
Identify the regulatory requirements during a product`s lifecycle.
Outline the steps required to ensure that a device meets registration requirements.
Outline the steps required to obtain a license to manufacture.

JOB POSTINGS:

608 Device Regulatory jobs found.
Displaying jobs #1-4.

Senior Device Developer – ASE 5
Posted Date: 2017-06-24
Kforce Technology – United States, CA, San Leandro, 94577

Director, Regulatory Affairs Promotional Materials
Posted Date: 2017-06-25
Pharmacyclics – United States, CA, Sunnyvale, 94091

Looking for a career in Medical Device Sales?
Posted Date: 2017-06-24
Medical Sales Recruiting – United States, AZ, Tucson, 85718

Packaging Engineer/ Medical Device/ Manufacturing
Posted Date: 2017-06-26
Confidential Client – United States, MI, Grand Rapids, 49953

See more Device Regulatory Jobs


For more information on the dinaris.org’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) 111-1111, or email Support@BioPharmaInstitute.com.

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