|Duration: 1.5 hours (the average time to complete the training program, including final assessments).
Credits Hours: 1
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 $149.00
Training Program: Medical Device Regulatory Affairs: Global Quality Management Systems, the Requirements
Training Provided By: BioPharma Institute
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 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.
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: Global Quality Management Systems, the Requirements course is found in the following professional certification program(s):
ANALYSIS, IMPROVEMENT & DOCUMENTS
CERTIFYING THE QMS
State how ISO 13485:2003 relates to the medical device industry
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.