Establishing Quality Systems is one of the central aspects of a medical device and/or pharmaceutical organization. Establishment of Quality Systems is also a regulatory requirement, as set out by the FDA and the ISO.The process of establishment of Quality Systems for FDA-regulated medical devices industries is set out in 21 CFR Part 820. Further, the ISO has its standard for how to establish Quality Systems in medical devices industries –the ISO 13485 standard –which has to be implemented as…See More
Medical device hazard analysis is of vital importance to a medical device. Medical device hazard analysis is at the heart of medical devices because if the device is not analyzed thoroughly for the hazard, or danger, that it poses, it is likely to cause problems of any kind to the user. Many a time, it becomes a matter of life and death. This is why medical device hazard analysis is of foremost importance.So, what is medical device hazard analysis? Medical device hazard analysis may be defined…See More
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
Can you have an inside storage room for flammable and combustible liquids that is greater than 500 square feet? Of course with an adequate fire suppression system, explosion-proof fixtures and…Continue
Where does everyone go for up-to-date workplace fire statistics - injuries, damage costs, etc. Is there a particular site you like or do you just wait for National Safety Council's annual report?Continue
Started by Michelle Sears. Last reply by Kevin Moore Aug 14, 2012.
A member of my association is putting together a safety manual for his new employer and would appreciate it if anyone has a Fire Prevention safety manual section or program that they would be willing…Continue
Started by Cory Zielke. Last reply by Kevin Moore Aug 14, 2012.
I have a question regarding UL testing procedures used to rate dry chemical extinguishers. What testing protocols does Underwriters Laboratory use to determine portable dry chemical extinguisher…Continue
Started by Paul Moore. Last reply by Paul Moore Apr 23, 2009.
It is my understanding that when pressurized cylinders are placed or used on a cart having a bottom lip around the base where the cylinder sits, this lip qualifies as one of the two securing points.…Continue