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Justin Osmond, MA

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Canada

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1 to 5 of 10 total

Expected life of the device

Posted By Justin Osmond 17-Sep-2019 09:39
Found In Egroup: Regulatory Open Forum \ view thread
Hi All,  Can someone point me to the FDA regulations related to device life / expected useful life?  Kind regards, ------------------------------ Justin Osmond MA Sr. Regulatory Affairs Specialist Ottawa ON Canada ------------------------------

RE: AAMI TIR102:2019 U.S. FDA 21 CFR mapping to the applicable regulatory requirement references in ISO 13485:2016 Quality Management Systems

Posted By Justin Osmond 12-Sep-2019 06:56
Found In Egroup: Regulatory Open Forum \ view thread
Thanks, everyone. Very helpful to get your impressions and experience. ------------------------------ Justin Osmond MA Sr. Regulatory Affairs Specialist Ottawa ON Canada ------------------------------

AAMI TIR102:2019 U.S. FDA 21 CFR mapping to the applicable regulatory requirement references in ISO 13485:2016 Quality Management Systems

Posted By Justin Osmond 11-Sep-2019 09:31
Found In Egroup: Regulatory Open Forum \ view thread
Hi All,  Is everyone jumping on this? Looks pretty interesting if one is building or updating a QMS for MDSAP. I'm wondering if anyone has purchased it and would recommend. Thank you! ------------------------------ Justin Osmond MA Sr. Regulatory Affairs Specialist Ottawa ON Canada --- ...

RE: IVDR classification of genetic tests

Posted By Justin Osmond 02-Jul-2019 06:38
Found In Egroup: Regulatory Open Forum \ view thread
Hi Dan, Thank you for the kind offer to classify the device in question. I will reach out if we need to take the next steps.  Kind regards, Justin ------------------------------ Justin Osmond MA Sr. Regulatory Affairs Specialist Ottawa ON Canada ------------------------------

RE: IVDR classification of genetic tests

Posted By Justin Osmond 10-Jun-2019 06:10
Found In Egroup: Regulatory Open Forum \ view thread
Thank you, Dan. That is very helpful.  "When you finish, review the classes identified and select the highest class. That is the device class."  --- I take you to mean that the device Class is C (as a genetic test), but we have to additionally meet any specific requirements for self-testing for non-critical ...