Medical devices classification by health canada


1- part one Choose a fairly complex medical device (ideally II or higher) and walk through the risk classification schema established by Health Canada. Provide a brief justification for your class assessment based on Health Canada’s risk classification schema.

2- Part 2: In a less than ½ page, what is ISO 141555 and what are the attributes of this standard? What role does this standard serves in medical device ITAs involving humans?