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Medical Device Regulatory Affairs: Global Quality Management Systems, the Requirements (MDG2)

Certification Training
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Method of Training: Online / Self-paced eLearning.
Credit Hours: 1 credits.
Duration: ~1 hour(s).
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.

Contact the Biopharma Institute for more information.

Document a dedication to your career and job performance by earning a training certification from Biopharma Institute.

Biopharma Institute LogoTraining Program: Medical Device Regulatory Affairs: Global Quality Management Systems, the Requirements
Training Provided By: Biopharma Institute

Schedule: Self-paced. Immediate access to training materials upon ordering.

Description: Online training with immediate access upon enrollment. Biopharma Institute Reviews

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 BioPharma Institute

Over the years, the BioPharma Institute, 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) 424-6576 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 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.


1. Welcome
2. Introduction
3. Assessment

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

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

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

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

30. Summary



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.

The Medical Device Regulatory Affairs: Global Quality Management Systems, the Requirements Course is Included in the Following Professional Certification Programs:

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

Online Training: The Benefits of 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 requirements.
  • 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.

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