Hi,
I am working in QA for a medical device start-up company. I am currently working to update our procedure for Vigilance reporting (MDD compliant) to also make it compliant with both FDA and Health Canada requirements.
What I find difficult is not to write the procedure, but how to structure/ compile it, so that the requirements for all countries are part of it without creating any mix-up/confusion.
Thank you. Any idea is very much appreciated!
I am working in QA for a medical device start-up company. I am currently working to update our procedure for Vigilance reporting (MDD compliant) to also make it compliant with both FDA and Health Canada requirements.
What I find difficult is not to write the procedure, but how to structure/ compile it, so that the requirements for all countries are part of it without creating any mix-up/confusion.
Thank you. Any idea is very much appreciated!