We are an ISO 9001:2000 certified, established manufacturer (and designer) of medical devices interested in expanding to Canada and the EU.

What additional requirements should we expect to apply to our existing product files in order to meet their regulatory requirements? (We are considering ISO 13485 certification)

Thanks,
SteveTIB

Likely, you will need to have your device approved for CE-Mark against the Medical Device Directive, by a Notified Body, in order to place your product in Europe.

For Canada, you will have to undergo the CMDCAS approval established by Health Canada.

There are a lot of threads on this issue here @ The Cove.

Steve,
ISO 13485 is a prerequisite for achieving CMDCAS certification so you would need this before you could apply for that certification and sell devices in Canada.
13485 is not required for CE certification but it certainly helps. The Medical Device Directive defines requirements for CE certification, which is required before selling or marketing devices in the EEC.

We are an ISO 9001:2000 certified, established manufacturer (and designer) of medical devices interested in expanding to Canada and the EU.

What additional requirements should we expect to apply to our existing product files in order to meet their regulatory requirements? (We are considering ISO 13485 certification)

Thanks,
SteveTIB
Hii Steve.
As i gather, you are based out of USA. Hence as said above CE mark notification from a notifying body is essential and the ISO 13485 certification + you have to appoint a EU authorized rep in Europe and respect all the labelling requirements (languages included) and register your products in the EU through your appointed rep. Not knowing what devices you intend to market, you need to classify the device seperately for the EU directive as well as per the MDR of Canada, and apply the requirements
For the Canada, your ISO 13485 must be from a CMDCAS accredited registrar and have to apply for the device licence. While getting thru your CE mark you could consider getting the C/US mark for your products and this helps in Canada much. Perhaps UL in your country will be much happy to do this or check with your existing ISO 9001 certifying body. A systamatic approach will help in meeting both regions requirements with ease....
Good luck