Medical Device Academy



Name: FORMTEXT ?????Company: FORMTEXT ?????Title: FORMTEXT ?????Email: FORMTEXT ?????Phone: FORMTEXT ?????Please answer the following questions by checking the appropriate box or by filling in the blank. This exam is open book, open notes, a copy of the “SOR/98-282” () and GD210 () are recommended as the preferred reference documents. A passing score is 7 out of 10 questions correct. Completed exams should be emailed to rob@.Who does Standards Council of Canada Audit (i.e. – accredit)? FORMCHECKBOX Health Canada FORMCHECKBOX Recognized Registrars FORMCHECKBOX Medical Device Manufacturers FORMCHECKBOX All of the Above FORMCHECKBOX None of the AboveHow many registrars are recognized by Health Canada under the CMDCAS program (not including TGA)? FORMTEXT ?????What does the Acronym CMDR Stand for? FORMTEXT ?????Which of the following decisions must be made if your company has a product failure complaint that involves a death or serious injury in Canada? FORMCHECKBOX the need for Vigilance Reporting FORMCHECKBOX the need for Medical Device Reporting FORMCHECKBOX the need for Mandatory Problem Reporting FORMCHECKBOX None of the AboveWhich parts of the CMDR apply to a Class II device manufacturer in the USA that is NOT distributing custom-made products and is not performing clinical studies or participating in the Special Access Program? FORMCHECKBOX Part 1 FORMCHECKBOX Part 2 FORMCHECKBOX Part 3 FORMCHECKBOX Part 4 FORMCHECKBOX Part 5 FORMCHECKBOX All of the above FORMCHECKBOX None of the AboveWhich of these two steps occurs earliest in steps to distributing medical devices in Canada? FORMCHECKBOX Canadian Medical Device License Application FORMCHECKBOX ISO 13485 CertificationIf a device is classified as Class IIa under Rule 2 in the EU for CE Marking, which of the following rules should you review first in the Canadian device Classification Rules? FORMCHECKBOX Rules 1-3 FORMCHECKBOX Rules 4-7 FORMCHECKBOX Rules 8-12 FORMCHECKBOX Rule 13-16What is Health Canada’s preferred format for Technical Documentation? FORMCHECKBOX Canada has its own unique format FORMCHECKBOX the same format as the US FDA 510(k) submissions FORMCHECKBOX a Technical File in accordance with NB-MED 2.5.1/rec 5 FORMCHECKBOX a Technical File in accordance with GHTF SG1/N011:2008Where do auditors from recognized registrars find their audit checklist questions for CMDCAS audits? FORMCHECKBOX ISO 19011 FORMCHECKBOX ISO 17021 FORMCHECKBOX GD210 FORMCHECKBOX Health Canada’s “Blue Book”When was the last amendment to the CMDR? FORMCHECKBOX December 8, 2014 FORMCHECKBOX December 16, 2011 FORMCHECKBOX June 1, 2009 FORMCHECKBOX None of the above ................
................

In order to avoid copyright disputes, this page is only a partial summary.

Google Online Preview   Download