Hi,
I found a lot of interest discussions on this website and useful material. I couldn't found enough information on software development procedures.
Perhaps I need to look in a different discussion thread and not in the medical devices discussion group, but the guidelines for MD are different and procedures must go after them.
We had several interest interpretations between my colleagues in our organization.
The different interpretations are based on the official standards and guidelines published by the FDA and Medical Devices Guidelines and I thought it could be useful to publish our last draft for comments on your website.
I know that for several issues there are no fixed rules but I want to hear from your experience and I opened for suggestions.
One of the issues I want you to received inputs are the responsibility of a QA on software development and if you need to add other milestones.
I hope it is not too long, readable and useful for the discussion.
Any answers will be appreciated.
Regards,

Hi,

I support our software development group here. We produce Radiation Therapy Planning software a Class II medical device. I haven't had a chance to read your procedure but just wanted to let you know that the "QA" role here has evolved since I took it over 4 years ago. In our company there are various locations that also develop software and the QA role is not consistantly done.

Like to discuss approaches more...I'll read your procedure and give you feedback!

Linda

Hi Linda,
Did you review the procedure? Do you have any comments?
I'll be glad to receive feedback
:-)
We have a meeting this week and I just want to hear different opinion.
:tg: