Profile

Concur with your response. We have dual facilities less than a mile apart. I had registered both locations as separate entities and was informed that they can be "grouped" as a single site. ------------------------------ Gregory Kleinert Warrington PA United States --------------------------- ...

What we have seen appears to be for new device applications. The test itself is usually done comparatively to a predicate device, which device.  The test is big $, gauging any tendencies towards requiring this test. This is specifically listed in the 10993-4 (017). ------------------------------ ...

Items responded are accurate. By and large, validating the process and the decisions made form the information is where the findings would develop. With a "packaged" system, validating the activities is nearly impossible. However, validating the "decisions" and verifying the risks associated are key ...

Hi All: Recently we have seen a large increase the requirement for this test. I was wondering if any of the community has experienced an increase in this or other ISO 10993 test requirements. One request I can chalk up to a reviewers interest area, however, with multiple requests, is there a change ...