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Tuesday, June 27, 2017
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Medical Device Regulatory Affairs: Global Quality Management Systems, the Requirements (MDG2)

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 Quality Management Systems, the Requirements
Training Provided By: dinaris.org
Website: http://dinaris.org

Availability: Immediately available upon ordering.

Description: Online training with immediate access upon enrollment.

This course details the regulatory expectations for quality management system (QMS) certification, identifies vital elements of the essential and standard administration roles, and explains how ISO 13485:2003 (the ISO standard) relates to the medical device industry. The key differences between ISO13485 medical device and ISO 9000 QMS are presented and discussed. The course objectives are to recognize how the QMS is to be certified by an external auditing authority, to identify some key roles in administration of the QMS, to identify the resources needed and the key areas of the QMS, and to state how ISO 13485:2003 relates to the medical device industry. This course is also included in the Global Medical Device Regulatory Affairs Professional Certification Program.

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

Benefits of Getting Certified at dinaris.org

Over the years, the dinaris.org, in addition to providing online training, has also been relevant in the development of other healthcare and biotechnology businesses. We have also worked with many leading corporations, worldwide.

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 Quality Management Systems, the Requirements 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

THE STANDARD
4. Why Use ISO13485:2003?
5. Applying ISO13485:2003
6. Defining A QMS
7. Review

THE QMS
8. Introduction
9. Key Areas Of The QMS
10. ISO9000 Vs ISO13485
11. Resource Management
12. Product Realization
13. Planning For Product Realization
14. Customer-Related Processes
15. Design & Development
16. Purchasing & Vendor Assurance
17. Production & Service Provision
18. Control Of Production Processes

ANALYSIS, IMPROVEMENT & DOCUMENTS
19. Measurement & Analysis I
20. Measurement & Analysis II
21. Measurement & Analysis III
22. Improvement
23. QMS Documentation
24. Company Responsibilities
25. Review I
26. Review II

CERTIFYING THE QMS
27. Iso 13485 Certification
28. What To Expect During An Audit
29. Review

CONCLUSION
30. Summary

GLOSSARY/RESOURCES

COURSE OBJECTIVES:


State how ISO 13485:2003 relates to the medical device industry
Identify the key areas of and resources needed for the Quality Management System (QMS)
Identify some key roles in administration of the QMS
Recognize how the QMS is to be certified by an external auditing authority.

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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