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
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