How does a startup best meet the QMS and ISO 13485:2016 requirements for bringing a new medical device to market in Canada?

I am part of a small startup that has designed a Class II medical device and are now ready to bring it to market in Canada. We have read over the copious amount of online documents regarding the requirements for medical license application, quality management systems, and ISO 13485:2016. We are now looking for guidance on what is needed and when, and defining a roadmap and strategy for brining the product to market.


Canada is very big market for medical devices due to its extensive health care programs.You only need to make clear Usage/Substance of Concern Guides/leaflets so that authorities can clearly understand about the product.

Answered 4 years ago

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