Medical Device Quality Management: Documentation and Records (MDQ2)
|Duration: 2 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 $199.00
Training Program: Medical Device Quality Management: Documentation and Records
Training Provided By: dinaris.org
Availability: Immediately available upon ordering.
Description: Online training with immediate access upon enrollment.
Control, implementation, and development of documentation and records provide the foundation of a quality management system (QMS). It also provides the evidence of compliance with the FDA CFR 820 Quality System Regulations (QSRs) and the ISO 13485 standards. This course introduces students to records requirements, their controls, and medical device documentation. The course objectives are to describe the record and change control procedures, to list the regulatory requirements for documentation, to discuss the requirements of a device history file and the device master record, further explain the elements of quality system documentation requirements, and lists the objectives of the role quality system documentation. The course includes an introduction and topics such as documentation and record change control, product-related documentation, quality system documentation, and offers a conclusion that views the previously listed topics. The program also includes progress checks, links to external resources, and a glossary.
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.
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:
The Medical Device Quality Management: Documentation and Records Course is Found in the Following Professional Certification Program(s):
QUALITY SYSTEM DOCUMENTATION
DOCUMENTATION AND RECORD CHANGE CONTROL
–List the objectives of thorough quality system documentation.
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
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.