https://jasonpartin.com/wp-content/uploads/2018/03/7c4f6e_f23bccee33b24fe08a16238eae351069mv2-1.jpg 720 1280 jasonpartin http://jasonpartin.com/wp-content/uploads/2019/03/logo-jp-jason-partin-cropped-50-px-high.png jasonpartin2018-03-18 21:04:552019-04-22 18:39:48Take this quiz to see if you're ready for MDSAP
Take this quiz to see if you’re ready for MDSAP
3 minute read, or a 12 minute quiz, if you’re ready.
By January 2019, the Canadian government will require all companies selling medical devices in Canada to be certified under the Medical Device Single Audit Program (MDSAP). There are only a few circumstances in which this deadline can be extended.
If you’re familiar with MDSAP, this article quizzes your knowledge of key concepts. If it’s new to you, read how to prepare for MDSAP.
MDSAP allows medical device companies to sell products in multiple countries with one audit. To help you prepare, I created a guide to MDSAP and this quiz.
If you can answer all questions in this quiz, you should be able to discuss three questions with anyone, at any level, in your company:
Is MDSAP right for your company?If so, are you ready for a MDSAP audit?If you’re not ready, what steps can you take to prepare?
How many countries are participating in MDSAP? List them.Is MDSAP mandatory for all participating countries?Does MDSAP add regulatory requirements beyond existing ISO 13485 and country-specific requirements?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?
When will Canada require MDSAP for most companies?
Under what conditions will Canada accept alternative MDSAP routes or deadlines?
Which classes of medical devices apply to Canada’s MDSAP requirements? Check all that apply:
Class IClass IIClass IIIClass IV
Auditing Organizations and audit reports
What is an “Auditing Organization (AO)?”List two, fully-recognized AO’sIf an AO finds a score of 5, how long do they have to report that score to regulatory authorities?If your company receives a MDSAP score of 5, how long do you have to submit a corrective-action plan?How many tasks with scores of 4 result in the same action as one score of 5?If your company has no scores of 4 or 5, how long does an AO have to submit a report to participating countries?
How many quality-system “processes” are identified by MDSAP? List them.
What is task 7 for the process “Production & Service Controls?”
Which ISO 113485 clause(s) are used for task 7?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
Use the MDSAP two-step grading system to answer the following questions.
Scoring matrix via Australia’s TGA
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?
Repeat question #1, but as a second audit, with the previous finding documented and uncorrected.
What is the Step 1 grade?What is the Step 2 grade?What is the final grade?Would an AO report this grade to regulatory agencies or simply include it in their final audit report?
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?
Would MDSAP be useful for your company? Why or why not? (Hint: use the “readiness” questions in how to prepare for MDSAP)
Do you believe your company is ready to pass a MDSAP audit?If your company isn’t ready, what are two things you could do to start getting ready?List three consultants or consulting companies that provide MDSAP training or consulting.
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.
Canada’s MDSAP updatesSearch “MDSAP” in the
CONSULTING OR TRAINING
AUDITING ORGANIZATIONS (AO’s)
MDSAP guideMC Hammer, Vanilla Ice, and the process-based quality approachThat’s not a knife! Crocodile Dundee on how to make risk-based decisions in supply chains
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