Hi there! We are a small (three employees!) medical device manufacturer of a class 2, 510k waived medical device (device #1). We have a QMS system that has passed FDA audit (whew!) to support this device and its distribution. We may be soon registering a new device (device #2) that is not 510k waived with the FDA, so we need to develop an additional QMS system for this device.
Whilst building out the QMS system for device #2, we'd like to improve the current QMS system for device #1 (it's "good enough" but the FDA audit did highlight some gaps in our understanding of the system and we think we'd benefit from a professional to come in and make it more cohesive). We don't just want to duplicate the current QMS documentation for the new device if we believe it could be better.
As a very small team, we do not have the bandwidth or the knowledge to improve the system for device #1 and build out the system for device #2. Now comes my question-- in your experience, what is the best source to assist us with this task? We are more focused on someone to come in and work almost exclusively on creating/ improving documentation for the system versus consulting/ training on system adherence. Should we engage a consultant? A company? Software? Purchase a template? Any cost insight would also be beneficial if you are comfortable sharing.
Doesn't have to be a specific recommendation, any direction or advice would be so helpful! Thank you in advance-- it is much appreciated!
Whilst building out the QMS system for device #2, we'd like to improve the current QMS system for device #1 (it's "good enough" but the FDA audit did highlight some gaps in our understanding of the system and we think we'd benefit from a professional to come in and make it more cohesive). We don't just want to duplicate the current QMS documentation for the new device if we believe it could be better.
As a very small team, we do not have the bandwidth or the knowledge to improve the system for device #1 and build out the system for device #2. Now comes my question-- in your experience, what is the best source to assist us with this task? We are more focused on someone to come in and work almost exclusively on creating/ improving documentation for the system versus consulting/ training on system adherence. Should we engage a consultant? A company? Software? Purchase a template? Any cost insight would also be beneficial if you are comfortable sharing.
Doesn't have to be a specific recommendation, any direction or advice would be so helpful! Thank you in advance-- it is much appreciated!