|Duration: 1.7 hours (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
Training Program: Medical Device Regulatory Affairs: US 510(k) Premarket Notification Scheme
Training Provided By: BioPharma Institute
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 BioPharma Institute
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. With expertise in the management of large training projects, the BioPharma Institute 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.
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:
The Medical Device Regulatory Affairs: US 510(k) Premarket Notification Scheme course is found in the following professional certification program(s):
OVERVIEW OF REGULATORY REQUIREMENTS
TYPES OF 510(k)
ADDITIONAL 510(k) REQUIREMENTS
SUPPORTING 510(k) DOCUMENTATION
510(k) SUBMISSION PROCESS
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.
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 Support@BioPharmaInstitute.com.