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Dma 3136 Iapdf Internal Quality Improvement Program Attestation Form

Dma 3136 Iapdf Internal Quality Improvement Program Attestation Form

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hi this is rob packard from medical device academy sorry it's been about a month since i joined you live on youtube today we're going to talk about quality system planning and changes if you haven't been aware uh canada made uh recently in the last year a big change to their quality system requirements in the regulations um they have a section on post-market surveillance they have a section on adverse event reporting they called it mandatory problem reporting but back in december of 2020 they released a new law i believe the the law was vanessa's law and that resulted in new regulation for health canada and the new regulation is called sor 2020-262 and so that's the code of the regulation just like in the u.s we have 21 cfr 820 for health canada there this new regulation is sor 2020-262 and the new regulation is specific to two areas the first half was implemented by june of this year and it's already in the regulation the canadian medical device regulation is sor-98282 so in that regu

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