Did You Know?
Sounds like a dream come true! Did you know that some medical device companies may be able to "avoid" FDA inspections?
Those medical device companies that operate in countries that are members of the GHTF (Global Harmonization Task Force) and that have successfully completed an ISO 13485:2003 based audit (conducted by another GHTF member) may be allowed (see recent draft guidance) to submit the ISO audit results in place of the inspection which would otherwise be required by the FDA.
To read more about this topic please visit the International Medical Device Regulatory Monitor.