Tips on passing Certified Medical Device Auditor (CMDA) exam
Tian Yu
2 Posts

Hi Everyone,
I hope you are doing well!
I will be taking my first CMDA exam in early March. I have so far read through the handbook twice and did all the questions in the CMDA question bank offered by ASQ. However, my mock exam score still hovers about 70%, far from passing. This is very frustrating and I don't know what else I can do other than keep studying...😓

Is there anyone who has just passed the exam and is willing to share their experience?
What else can I do to study and better prepare for the exam? Any tips are welcome!
Thanks in advance!

10 Replies
John Ross
11 Posts
passing the exam is more about having the acquired knowledge and experience of an auditor, not just studying a book and test bank questions. An auditor needs to understand and apply the fundamentals when auditing, otherwise the auditee will be the one to suffer.
Tian Yu
2 Posts


Thanks so much for your reply! It's always encouraging to hear from professionals in the field. As someone with sufficient experience to take the exam, I feel like it would be an honor and responsibility if given this opportunity to hold the certification - which is why my goal has been continuous learning throughout all aspects of preparing (and studying!). Thanks again and wish me luck!

Hi Tian

I am also preparing for the exam so i do understand your concern. That said, I have a lot of experience in the medical devices field as a biomedical engineer together with experience and certification as a manger of quality so this has helped me in passing scores. That said I would suggest that you focus on the weaker areas based on the mock exam scores to try and strengthen and review specifically these chapters in the text. From what I have seen the exam is quite practical oriented so you really need to draw on your practical experience.

Good luck and I am sure you will succeed!


In a general way, the questions are structured so that there is a correct answer and two clearly incorrect answers, but there is one distractor choice that sounds good, but is there to catch if you are just guessing. Make sure you focus carefully on the question, because the choice you are picking might be a correct statement, but not the best answer to the question. So do go back and review the question again carefully for which is the BEST answer before you select your choice.

The exam can be intimidating; however I always tell colleagues sitting for the CMDA or CQA exam “you know this - you do it everyday" . Answer the questions you are sure of first, then go back, use your reference materials and follow your gut instincts on those you are in doubt of the answer.

Here's my advice: There are other books listed in the lists of recommended readings. Find them and read them at least twice. You will need to know the acceptable levels for the Waste Standard (remember, you can take material in with you). Be prepared - the first question on the exam is one that has nothing to do with CMDA. Don't let it throw you. I ended up reading the handbook three times and the other books twice. I collected over 50 documents which were referenced in the test and read them all. If you don't pass, you can retake just what you failed. As a word of encouragement, I didn't do that well on the practice tests, but passed the exam anyway first try. Good luck and stay calm.

Alison Ho
2 Posts

I agree with Michele here. I just took the CQA exam for the first time this month and passed. When using the question bank questions I kept getting 70's. Doesn't give you a warm fuzzy feeling that you know your stuff. But performing and managing quality audits for 12 plus years I knew I knew my stuff and banked on that. I felt the actual exam was easier then the question banks. Many of the questions you will not find the exact answer in the book. Its based on critical thinking and application of concepts and methods. Focus on the areas where you are weakest when studying. Good luck! You will do great!

Hello Yu, I am preparing for my CMDA certification exam and wondering if you will be willing to share your prep strategy so far? Please let me know.

What experience I have with this process (I was invited to the round table of about 12 exam people for CMDA a few years ago--invited from industry) is that there is no pattern. wordle io games

What experience I have with this process (I was invited to the round table of about 12 exam people for CMDA a few years ago--invited from industry) is that there is no pattern. wordle io games