Every medical device startup, at some point, needs to create a Quality System.
You can do it the easy inexpensive way or the hard expensive way.
The easy inexpensive way is to base your system on generic quality system SOP's and customize as needed. The hard expensive way is to custom write all the SOP's. A recent industry wide survey by Pathwise, a large consulting and training firm, showed that the majority of respondents take 3-5 days to write,edit, and rewrite one SOP and to create forms.
In addition, Medical Device SOP Advisors SOP's are guaranteed to keep you out of trouble with the FDA. They have withstood FDA review and are up to the minute in reflecting latest FDA thinking. FDA requirements are a moving target. They constantly increase their expectations of medical device developers. An example is the increased emphasis on usability studies. Don't forget that you will be audited by your customers and potential business partners to the same standards.
Our SOP's are inexpensive and will save you time and money and FDA grief. Help with customization is available. Click on "Services" in the menu at the left.
Please review our offerings. Click on "About Med Device Advisors" in the menu at the left.