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Tuesday, June 27, 2017
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Medical Device Regulatory Affairs: US 510(k) Premarket Notification Scheme (MDU3)

Certification Training Duration: 1.7 hours (the average time to complete the training program, including final assessments).
Credits Hours: 2
Demonstration: Demo an online course.

Certificate: View sample certificate.

PRICE: USD $169.00

dinaris.org LogoTraining Program: Medical Device Regulatory Affairs: US 510(k) Premarket Notification Scheme
Training Provided By: dinaris.org
Website: http://dinaris.org

Availability: Immediately available upon ordering.

Description: Online training with immediate access upon enrollment.

This course introduces the student to the required activities necessary before a device is ready to go to market in the United States. The US Regulatory Affairs Overview (MDU1) course is recommended as an introduction before taking this course. Course objectives consist of the following: To provide a description of the 510(k) submission process, to list the elements which are essential parts of a 510(k) submission, to introduce some examples of when items are required and when additional items are required, to introduce the 3 types of 510(k) submissions and provide examples of when they are required, to determine when a 510(k) is not required vs. when it is, and offer a description of the purpose of the Premarket Notification 510(k) Program.

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.

Benefits of Getting Certified at dinaris.org

By employing advanced e-learning training techniques, and coupling them with new automated tracking systems, the dinaris.org provides professionally designed online courses which are effective at training, and assist those with advancing their careers. The dinaris.org also assists companies through maintaining training records, the education of their employees, and assisting them with improving their overall quality of service. With expertise in the management of large training projects, the dinaris.org strives to assist professionals in furthering their understanding of the healthcare, pharmaceutical, and biotechnology industries, to help them uncover new discoveries within those fields, and assist in understanding the peripheral technologies contained within those industries.

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: US 510(k) Premarket Notification Scheme 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

COURSE OUTLINE:


COURSE OUTLINE

INTRODUCTION
1. Welcome
2. Introduction
3. Reviews and assessments

OVERVIEW OF REGULATORY REQUIREMENTS
4. Introduction
5. Medical device exemptions
6. Substantial equivalence
7. Regulatory requirements
8. Who needs to submit a 510(k)
9. When to submit a 510(k)
10. When a 510(k) is not required
11. Preamendment devices
12. Topic review

TYPES OF 510(k)
13. Introduction
14. The new 510(k) paradigm
15. Content of the 510(k)
16. Content of the Traditional 510(k)
17. Content of the Special 510(k)
18. Abbreviated 510(k)
19. Content of the Abbreviated 510(k)
20. Topic review

ADDITIONAL 510(k) REQUIREMENTS
21. Introduction
22. Sterilization and shelf life
23. Biocompatibility
24. Software
25. Electromagnetic compatibility
26. Performance testing
27. Topic review

SUPPORTING 510(k) DOCUMENTATION
28. Introduction
29. 510(k) cover letter
30. Cover letter design factors
31. 510(k) Summary or Statement
32. Truthful and Accurate Statement
33. Topic review

510(k) SUBMISSION PROCESS
34. Introduction
35. Acceptance and review
36. Requests for additional information
37. Decision letter

CONCLUSION
38. Summary I
39. Summary II

COURSE OBJECTIVES:


Describe the purpose of the Premarket Notification 510(k) Program.

Determine when a 510(k) submission is required and when it is not required.

List the three types of 510(k) submissions and give examples of when each is required.

List the essential elements of a 510(k) submission.

List the additional requirements and give examples of when they are required.

Describe the 510(k) submission process.

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

Medical Device Sales Representative
Posted Date: 2017-06-24
Hiossen Inc – United States, FL, Tampa, 33646

Medical Device Laboratory Technician (Lab Tech)
Posted Date: 2017-06-23
Medix – United States, IL, Mundelein, 60060

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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