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
ISQEM are pleased to announce the ISQEM Safety Conference USA in June 2013, Location: Las VegasThe conference will be one of the leading events of the year, which will allow delegates to meet a range…Continue
We have been throwing around the idea of incorporating more incentives for individual or work groups with zero incidents. Does anyone have any experience with this positive or negative? Does anyone…Continue
Started by Trinity. Last reply by Lyndon Pousson Mar 9, 2011.
Hi All! I am conducting an occupational safety and health training program for a group of Diesel Truck Repair Shop Safety employees and would like to get your input in regards to information they…Continue
Loved ones coming together is what the holidays are all about, but first you have to get there. This holiday season is expected to receive more travel on the roads than in previous years due to the…Continue