Happy New Year to all.
We are hoping to release our first product in the next month and once CE Marking is achieved, we will begin to target other territories. One of these was going to be Canada and I have read that the CMDR require you to be MDSAP certified before you can sell, as well as receiving clearance. I have a few questions that I was hoping people could assist with.
I had not been looking at the MDSAP program, has anyone gone through this?
Is this worthwhile, has it been adopted well? Do other countries mandate this?
What would be the average timescale for gaining MDSAP certification?
What costs are involved?
We are 13485 certified already and will hopefully receive CE clearance (under the MDR) shortly, is there a lot of work involved?
Sorry for all the questions, I am trying to gain some quick answers to determine whether we should look into it further or whether to just avoid Canada
Thanks for any help.
We are hoping to release our first product in the next month and once CE Marking is achieved, we will begin to target other territories. One of these was going to be Canada and I have read that the CMDR require you to be MDSAP certified before you can sell, as well as receiving clearance. I have a few questions that I was hoping people could assist with.
I had not been looking at the MDSAP program, has anyone gone through this?
Is this worthwhile, has it been adopted well? Do other countries mandate this?
What would be the average timescale for gaining MDSAP certification?
What costs are involved?
We are 13485 certified already and will hopefully receive CE clearance (under the MDR) shortly, is there a lot of work involved?
Sorry for all the questions, I am trying to gain some quick answers to determine whether we should look into it further or whether to just avoid Canada
Thanks for any help.