Hello RAPS Community,
I am looking for advice from someone who has recently submitted a Health Canada Medical Device Licence Application and/or an 510(k) for a software as a medical device (SaMD) product. Specifically, I am interested in discussing any submission materials particular to SaMD that were requested by regulators but not specifically mentioned in guidance documents.
Anyone with advice or comments, please don't hesitate to connect. Any help is greatly appreciated.
Thank you in advance.
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Breanne Cuddington
Senior Regulatory Affairs Associate
Kitchener ON
Canada
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