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
I am aware that scissor lifts do not fall under the aerial lift standards (although they should) but rather under the mobile scaffold standards. However, is there any standard someone can find about…Continue
Started by Garry L Mullins Jr. Last reply by Terry P. Keenan Oct 4, 2013.
Can anybody please give me a straight up answer on an exact date the new 2007 ASME B30.5 regulations take effect. Also when osha's C-DAC goes in effect. Every crane site and magazine i read praises…Continue
The campaign to stop falls in construction is well underway! In 2010, more than 10,000 construction workers were injured as a result of falling while working from heights. ASSE supports our Arizona…Continue
Started by Cory Zielke. Last reply by Lukeav - Lanier Upshaw Aug 2, 2012.