Take this quiz to see if you’re ready for MDSAP

Background

Quiz

1. How many countries are participating in MDSAP? List them.
2. Is MDSAP mandatory for all participating countries?
3. Does MDSAP add regulatory requirements beyond existing ISO 13485 and country-specific requirements?
4. If your company doesn’t plan to sell products in one of the MDSAP countries, do you still have to comply with that country’s unique requirements to pass a MDSAP audit?

1. When will Canada require MDSAP for most companies?
2. Under what conditions will Canada accept alternative MDSAP routes or deadlines? <hint>
3. Which classes of medical devices apply to Canada’s MDSAP requirements? Check all that apply:
   • Class I
   • Class II
   • Class III
   • Class IV

Auditing Organizations and audit reports

1. What is an “Auditing Organization (AO)?”
2. List two, fully-recognized AO’s.
3. If an AO finds a score of 5, how long do they have to report that score to regulatory authorities?
4. If your company receives a MDSAP score of 5, how long do you have to submit a corrective-action plan?
5. How many tasks with scores of 4 result in the same action as one score of 5?
6. If your company has no scores of 4 or 5, how long does an AO have to submit a report to participating countries?

Audit model

1. How many quality-system “processes” are identified by MDSAP? List them.
2. What is task 7 for the process “Production & Service Controls?”
3. Which ISO 113485 clause(s) are used for task 7?
4. If your company sells a product in Japan, list additional requirements for task 7, if any.

The image below is used by some regulatory agencies to summarize MDSAP processes and links. In your own words, explain the concepts this image is trying to convey.

Image thanks to Australia’s TGA

MDSAP grading

Use the MDSAP two-step grading system to answer the following questions.

Scoring matrix via Australia’s TGA

1. An AO discovers that a company has a procedure addressing ISO 13585:2016, clause 5.5, but did not follow it. This was the first finding, and it did not result in shipping a nonconforming product.
   • What is the Step 1 grade?
   • What is the Step 2 grade?
   • What is the final grade?
   • Would the AO report this grade to regulatory agencies within five days, or simply include it in their final audit report?
2. Repeat question #1, but as a second audit, with the previous finding documented and uncorrected.
3. Repeat questions #1 and #2, replacing clause 5.5 with clause 7.3.Repeat question #3, this time as if a nonconforming product had shipped.

Are you ready?

1. Would MDSAP be useful for your company? Why or why not? (Hint: use the “readiness” questions in how to prepare for MDSAP)
2. Do you believe your company is ready to pass a MDSAP audit?
3. If your company isn’t ready, what are two things you could do to start getting ready?
4. List three consultants or consulting companies that provide MDSAP training or consulting.

Conclusion

MDSAP is straight-forward and transparent. To paraphrase The Buddha, there are no secrets “hidden in the closed fist of the teacher.” If you weren’t sure about portions of the quiz, see these key resources, which include links to consultants and trainers to help larger groups gain understanding of medical device quality systems and regulations.

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Good luck!

Resources

Official documents

1. Canada’s MDSAP updates

Consulting and training

1. Oriel STAT-A-MATRIX, an international management consultancy (I consult with them)
2. Qunique, a boutique Swiss quality and regulatory consultancy
3. Me (Jason)

Auditing Organizations

1. Intertek
2. BSI Group
3. TUV SUD
4. UL