ASQ Medical Device Auditor (CMDA) Exam | How to Prepare

How to Prepare for ASQ CMDA Exam?

ASQ Medical Device Auditor Exam Summary: Vendor ASQ Exam Code CMDA Full Exam Name ASQ Certified Medical Device Auditor Number of Questions 145 Sample Questions ASQ Medical Device Auditor Exam Sample Questions and Answers ASQ Certified Medical Device Auditor (CMDA) Practice Test 550/750 Practice Exam Passing Score Time Limit 270 Minutes

CMDA Certification Syllabus Content: Syllabus Topics: I. Auditing Fundamentals II. Auditing and Inspection Processes III. Medical Device Quality Management System Requirements IV. Technical Medical Device Knowledge V. Quality Tools and Techniques (15 Questions)

ASQ CMDA Training: Recommended Training: Certified Medical Device Auditor Certification Preparation

How much Fees of ASQ CMDA Exam? ASQ CMDA Fee Structure: Total appointment time- 270 Minutes Exam Time - 258 Minutes

CMDA Study Guide: Know about ASQ Medical Device Auditor book details. Go through ASQ CMDA exam syllabus. Go through ASQ Medical Device Auditor sample questions. This will give you a clear idea about the real exam. Enroll for CMDA practice test on ProcessExam.com. Identify your weak areas from CMDA sample exam and do more practice with system.

ASQ Medical Device Auditor Sample Questions

Que.: 1. FDA CPG 7382.845 is critical for understanding the FDA's criteria for _______ based on quality system audit results. Options: a) regulatory action b) market approval c) financial penalties d) product recalls

Answer: a) regulatory action

Que.: 2. The impact of nonconformances in an audit report is significant. What is the primary purpose of detailing these impacts? Options: a) To allocate blame to specific individuals b) To highlight areas for improvement c) To assess the financial loss only d) To promote alternative products

Answer: b) To highlight areas for improvement

Que.: 3. When applying the elements of CAPA, which of the following is critical in ensuring the effectiveness of corrective actions? Options: a) Prioritizing actions based on financial impact b) Focusing on actions with the easiest implementation c) Prioritizing actions based on risk d) Assigning responsibility based on department seniority

Answer: c) Prioritizing actions based on risk

Que.: 4. For products that require traceability under 21 CFR 820, which of the following is essential? Options: a) Tracking the product through its entire life cycle b) Maintaining a customer database c) Ensuring the product is cost-effective d) Prioritizing product aesthetics

Answer: a) Tracking the product through its entire life cycle

Que.: 5. Auditor independence ensures that the audit is free from ________ bias. Options: a) Technical b) Financial c) Personal d) Educational

Answer: c) Personal

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