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
Business Communication systems are the processes, both informal and formal, by which information is passed between the employers and employees within a business, or between the business itself and…Continue
Started by Chris John. Last reply by Jay D. Rohman Jun 29, 2016.
A member of my association (the American Society of Safety Engineers) asks for information on the following:I have heard cloud computing may have greater risk for third party subpoenas and government…Continue
Started by Cory Zielke. Last reply by Chris John May 27, 2016.
The business of managing risk is changing. Take advantage of this opportunity to examine best practices, discuss trends, learn new technologies, and much more, as ASSE (the American Society of Safety…Continue