JoCam
Trusted Information Resource
Hi All,
I have pulled together all the documents and information required for pre-market licence application of our Class III medical device to Health Canada. I've also compiled a 65 page report covering the requirements of Module 1 and Module 2. This is where I've ground to a halt.
Even though I have the GHTF/SG1/N011:2008 and Health Canada guidance document for compilation of this submission, I am struggling with how to put it all together. The Table of Contents format mentions sub-sections, sections, volumes and tabs which has totally confused me. Can anybody explain to me exactly how they would like the submission presented?
Your help on this matter will be very much appreciated.
Thank you,
Jo
I have pulled together all the documents and information required for pre-market licence application of our Class III medical device to Health Canada. I've also compiled a 65 page report covering the requirements of Module 1 and Module 2. This is where I've ground to a halt.
Even though I have the GHTF/SG1/N011:2008 and Health Canada guidance document for compilation of this submission, I am struggling with how to put it all together. The Table of Contents format mentions sub-sections, sections, volumes and tabs which has totally confused me. Can anybody explain to me exactly how they would like the submission presented?
Your help on this matter will be very much appreciated.
Thank you,
Jo