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Home » Medical Device Regulatory Affairs: US Quality Systems Requirements, 21 CFR 820

Medical Device Regulatory Affairs: US Quality Systems Requirements, 21 CFR 820 (MDU2)

Certification Training
Rated 3.73/5
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Duration: 1.7 hours, Online (the average time to complete the training program, including final assessments).
Credits Hours: 2
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
Catalog: Medical Device Regulatory Affairs.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.

PRICE: USD $169.00

BioPharma Institute LogoTraining Program: Medical Device Regulatory Affairs: US Quality Systems Requirements, 21 CFR 820
Training Provided By: BioPharma Institute

Availability: Immediately available upon ordering.

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

Implementing a quality system for medical devices can be a complex process. This model will help you to assimilate all of the required knowledge necessary to implement a quality system in accordance with the 21 CFR 820 regulations. Course objectives are: To identify what documentation is required for quality system, to explain the role of key stakeholders in maintaining and establishing a quality system, to identify the requirements of the quality system, and to state how 21 CFR 820 relates to the medical device industry. The course includes an introduction and topics such as production assurance, responsibilities and roles, quality systems, FDA inspection, product documentation, quality assurance, and a conclusion that summarizes the previously listed topics.

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

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By employing advanced e-learning training techniques, and coupling them with new automated tracking systems, the BioPharma Institute provides professionally designed online courses which are effective at training, and assist those with advancing their careers. The BioPharma Institute also assists companies through maintaining training records, the education of their employees, and assisting them with improving their overall quality of service.

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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 >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.

The Medical Device Regulatory Affairs: US Quality Systems Requirements, 21 CFR 820 course is found in the following professional certification program(s):

US Medical Device Regulatory Affairs Professional Certification Program: This online certification program provides an introduction to the Code of Federal Regulations (CFRs). It introduces students to the activities that are essential prior to a device being set to go to the United ... Learn more


1. Welcome
2. Introduction
3. Reviews and Assessments

4. Overview of 21 CFR 820
5. Quality System Definition
6. More on Quality Systems
7. QSRs
8. Implementation
9. Quality System Linkages

10. Overview
11. Management
12. Management Representative
13. Company Personnel
14. Review

15. Overview
16. Product Assurance
17. Design Control Overview
18. Design Control
19. Purchasing Control
20. Identification/Traceability
21. Process Control
22. Control of Production Processes
23. Process Validation
24. Device Labeling
25. Handling

26. Overview
27. Acceptance Activities
28. Nonconforming Products
29. CAPA
30. Servicing and Repair
31. Statistical Techniques
32. Review

33. Overview
34. Device Master Record
35. Device History Record
36. Complaint Files
37. Review

38. Introduction
39. Inspection Procedure
40. FDA Inspection Guidance

41. Summary


State how 21 CFR 820 relates to the medical device industry.
Identify the requirements of the quality system.
Explain the role of key stakeholders in establishing and maintaining a quality system.
Identify what documentation is required for quality system.

Online Training Program Benefits:

  • Immediate access to training: Instructions, username, password and receipt of payment 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 180 days for professional certification programs
  • Flexible final assessments: Tests include multiple-choice questions and can be taken repeatedly until a passing score is achieved
  • Direct access to certificates: Documentation instantly available once course requirements have been fulfilled
  • Verification of training: Certificates can be verified online, and electronic badges are issued for all Professional Certification programs
  • Tuition reimbursement: Some employers may reimburse for training expenses; check on your company's requirements
  • Purchase orders (POs) accepted: If POs are required, 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 offer an encrypted connection with firewall protection and daily scans for optimal level of security and performance
  • Career advancement: Professional certifications could be helpful for those seeking new careers or transitioning to different positions within their organization

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, or email

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