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Implementation of Regulatory Aspects of Clinical Research is criticalOne of the prime areas of clinical studies is regulatory aspects of clinical research. This applies in almost equal measure to medical research as a whole. The FDA and other regulatory bodies have…See More
Safety is a goal. Safety is a mentality. Safety is effort. Safety is a work in progress. Safety is something every company should treasure. A quick look around and you’ll see professionals, organizations, schools and businesses touting their unwavering dedication to safety. But what does that mean? Some will point to their low incident…See More
A medical device has to mandatorily make a submission for premarket approval (PMA) to the FDA to demonstrate that the device to be marketed is substantially equivalent or at least as safe and effective as a non PMA-subjected legally marketed device. This submission is called 510 (K).A medical device company has to submit a product for PMA when it manufactures or makes changes and modifications that could substantially affect safety and effectiveness requirements under 21 CFR 807 and design…See More
The field of Health InformaticsHealth Informatics is catching up as a field of health and Information Technology. At its barest, it can be understood as being the area that concerns the use of IT in health. However, Health Informatics goes beyond being just this. It consists of the entire IT ecosystem in the healthcare industry, which means that individual healthcare units use IT via a connected…See More
I am seeing more and more health and safety professionals on Twitter sharing information, articles and links about workplace safety. In fact, you can now follow Ansell (creator of this fine social…Continue