K
Hi
I am the Quality Manager for a medical device company and up until now I have only been concerned with ISO 9001 and ISO 13485 (and all relevant directives etc) (I'm also pretty new to quality in general so please forgive my ignorance)
I have just been asked to take on board the creation of a software procedure (the company makes everything in house from hardware to software) - however I'm not even sure where to start or what standard to buy.
I feel a little bit like a duck out of water and they're wanting this quicker than ASAP haha!
Any help with pointing me in the right direction, even just where to start would be appreciated
Thanks, Katie
I am the Quality Manager for a medical device company and up until now I have only been concerned with ISO 9001 and ISO 13485 (and all relevant directives etc) (I'm also pretty new to quality in general so please forgive my ignorance)
I have just been asked to take on board the creation of a software procedure (the company makes everything in house from hardware to software) - however I'm not even sure where to start or what standard to buy.
I feel a little bit like a duck out of water and they're wanting this quicker than ASAP haha!

Any help with pointing me in the right direction, even just where to start would be appreciated
Thanks, Katie
