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Medical Device Auditor (CMDA)
The Certified Medical Device Auditor is a professional who understands the principles of standards, regulations, directives, and guidance for auditing a medical device system while using various tools and techniques to examine, question, evaluate, and report on that system's adequacies and deficiencies.
A medical device auditor analyzes all elements of the system and reports on how well it adheres to the criteria for management and control of process safety.
Download the Certified Medical Device Auditor Brochure
Download the Certified Medical Device Auditor Fact Sheet.
Cost
ASQ Exam Member Fee Rs. 34650
ASQ Non Member Fee Rs. 42650
Retakes Fee Rs. 26650
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More Information:
REQUIREMENTS
5
Years of on-the-job experience in one or more areas of the Certified Medical Device Auditor Body of Knowledge.
1
*Year of on-the-job experience must be in a "Decision-making" position.
Candidates must have worked in a full-time, paid role.
*A "Decision-making" position is defined as the authority to define, execute, or control projects/processes and to be responsible for the outcome. This may or may not include management or supervisory positions.
EDUCATION
Candidates who have completed a degree from a college, university or technical school will have part of the five-year experience requirement waived, as follows (only one of these waivers may be claimed):
- Associate degree — one year waived
- Bachelor's degree — three years waived
- Master's or doctorate — four years waived
You can apply for certification exam whenever you are prepared for the exam. you need to purchase the study material on your own.
For material – you can refer our US website (www.asq.org)
Each candidate is required to pass an exam that consists of multiple-choice questions that measure comprehension of the Body of Knowledge.
Computer Delivered - The CMDA examination is a one-part, 145-multiple choice question exam, and is offered in English only. 135 questions are scored and 10 are unscored. Total appointment time is four-and-a-half-hours, exam time is 4 hours and 18 minutes.
All examinations are open book. Each participant must bring his or her own reference materials.
For more information about examination delivery options, including online, remote proctored examination.
Included in the Body of Knowledge are subtext explanations and corresponding cognitive levels for each subtopic. These details will be used by the Examination Development Committee as guidelines for writing test questions and are designed to help candidates prepare for the exam by identifying specific content within each topic that may be tested.
The subtext is not intended to limit the subject matter or be all-inclusive of what might be covered in an exam, but is intended to clarify how topics are related to the role of the certified medical device auditor. The descriptor in parentheses at the end of each subtext entry refers to the highest cognitive level at which the topic will be tested. A more complete description of cognitive levels is provided at the end of the document.
Download the Certified Medical Device Auditor Body of Knowledge
PASS
If taking the exam CBT you will get your result immediately after submitting the exam. Within 3-5 business days you will receive an email confirming the result. ASQ will also send you a separate email with details on how-to claim your digital certificate and badge through the Accredible platform.
ASQ communicates exam results for exams with updated or new Bodies of Knowledge (pilot exams) within five weeks.
FAIL
If you do not pass your CBT exam you will receive a summary of your performance via email within 3-5 business days from your initial exam. For 2 years from your previous attempt you can apply at a significantly reduced "retake rate".
Computer-Based Testing Dates
ASQ certification examinations are delivered by ASQ's testing partner, Prometric.
The examination scheduling instructions in your eligibility letter will direct you to a section of Prometric's website, where you can select and schedule your examination date and location.
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