We have what we feel is not a unique situation and were wondering if anyone might of run across this challenge and know more about the requirements. We are building a small machine system that includes some pneumatic components and some heated plates inside a small guard system. We include emergency stops on the machine and if they are actuated it removes all electric current and dumps all air pressure from the machine. We have several electrically interlocked doors that can be opened to…See More
Quality and compliance are vital issues for any medical devices company. Despite the fact that the FDA’s regulatory compliance requirements are the same across the industry; many medical device companies are shocked when they receive a 483, or a Warning Letter, or even a consent decree. Is meeting the FDA’s regulatory requirements something of a chance, which some organizations get by fluke and others don’t?This is simply not the case. Quality and compliance are built into a medical device…See More
Having consulted in the patch and policed it for years the number on safety violation was not the offence but the attitudeNot doing the procedures as outline or letting consultant bully the workers…Continue
“Employee says he was trying to unstop a drain at the PS3B Unit on the premises when other workers resumed cleaning the area without notifying the employee or checking to see if he was still working…Continue
Started by Jay D. Rohman. Last reply by Jay D. Rohman Aug 19, 2009.
Hello people. im new in this community and this group and i have a clear indicationthat there are loads of benefits from this group.I have been trying to get the reason intake of juice is recommended…Continue
Started by Femi Samuel Oshajare. Last reply by Chester T. Karella C.S.P./C.E.T. Aug 19, 2009.