This says is all!!!, page-6

Hi Jazzman,

Without discussing AZV specifically, If I could answer in a more generic fashion:

Nursecall Systems are considered a Class II Medical Device, exempt from 510(k) (Pre-Market Approval). This means that you must list your medical device with the FDA and undertake to comply with QSR820. QSR820 is a similar standard to ISO13485, which in turn is a super standard of ISO9001. Like all quality systems, there is an implementation cost associated with its deployment and an ongoing maintenance cost of the quality system. Specifically with QSR820, which is designed for medical devices, it is important to track versions of products, have formalized risk analysis, audits et al - my experience has been about a 10% increase in costs for manufacturing and research and development expenses, with a small, incremental cost associated with Sales, Marketing and Management.

However, in saying the above, once the system is rolled out, then quality increases and your real costs decrease - but it takes several years to fine tune everything (at least in my experience!).

However, once you cross the threshold into integrating Point of Care Devices, such as patient monitors, then you move into the 510(k) arena, which incurs additional costs and regularity compliance.

I trust the above assists.