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An audit management system can be understood as a set of audit systems that an organization puts in place to ensure that it meets its objectives. All organizations need to have their own audit management systems. An audit management system is a system that facilitates the management of…
Added by Adam Fleming on October 19, 2016 at 5:40am — No Comments
Verification and Validation (V & V) are two important aspects of regulatory compliance for software. What all are needed for achieving this? The FDA, GAMP and others provide guidance in the methodology and documentation needed for this. This apart; consideration of the principles in ISO 14971 can assist in providing an acceptable vehicle by which to perform and document risk-based software V&V.…
Added by Adam Fleming on October 18, 2016 at 5:50am — No Comments
It is a disturbing, but true fact that medical devices are hacked. Medical devices have inbuilt software, and hackers try to breach this. Medical device cyber security is thus critical, because lack of it can bring harm to patients who use medical devices that come with software built…
Added by Adam Fleming on October 12, 2016 at 5:41am — No Comments
FDA Code of Federal Regulations (CFR) is a huge sea of regulations that the FDA has created for regulating all products that come under its purview of regulation. The FDA codes of federal regulations are numbered and cover all products, processes and the activities that go into their creation.
The FDA Code of Federal Regulations is a compendium of codified general and permanent rules the federal…
ContinueAdded by Adam Fleming on October 6, 2016 at 5:46am — No Comments
Documentation is at the heart of medical devices. If a medical device manufacturer cannot convincingly establish documentation of the manufacturing process; the medical device is bound to have regulatory approval hurdles. Every medical device manufacturer has to both establish and maintain all of these: documents, procedures and records, all of which must be under a state of control.
So, what should the documentation establish and prove?…
Added by Adam Fleming on September 13, 2016 at 6:52am — No Comments
Implementation of Regulatory Aspects of Clinical Research is critical
One 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…
ContinueAdded by Roger Steven on May 27, 2016 at 5:07am — No Comments
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…
Added by Adam Fleming on May 25, 2016 at 6:07am — No Comments
Leading pharmaceutical and biotech companies are increasingly under pressure to deliver effective new products in shorter time frames while minimizing the development costs. The structure, activities, resources of new product, planning regarding launch and successful commercialization of new product are main areas of focus of for medical affairs department in all the pharmaceutical companies. Many critical activities take place well in advance of the actual launch of a new…
ContinueAdded by Worksure Medpharma on April 6, 2015 at 3:00am — No Comments
Have you ever thought that the doctor wasn’t listening to you? Didn’t seem to understand what was important to you? Was talking in medical speak but not in a language you could understand? That he or she gave bad news to you and left you hanging as to what to do next? Unfortunately, these are all too common.
Medical advances such as new drugs, imaging devices, operating room technology and others are coming rapidly and greatly expanding what can be done for patients. But concurrently…
ContinueAdded by Stephen C Schimpff on May 20, 2012 at 7:43am — No Comments
Many harbor the concept that the recently passed reform legislation – The Patient Access and Affordable Care Act – will mean even greater advances in medical science. This is a misconception.
The reform bill is all about access to care – getting those without insurance to get insurance either through the commercial market place or through Medicaid. This will create at least 31 million more individuals with Medicaid, will keep young adults on their parent’s insurance for a…
ContinueAdded by Stephen C Schimpff on March 7, 2012 at 10:30am — No Comments
There are many misconceptions about health care and medical care. This includes the discussions over the last few years about healthcare reform but is not limited to those discussions. I plan to write about these over the coming days and weeks in some detail. Here is the first one. “American has the best healthcare system in the world.”
One of the first problems with this statement is that we really have a medical system in America not a healthcare system. We focus on…
ContinueAdded by Stephen C Schimpff on February 7, 2012 at 11:25am — No Comments
Medical billing software has become an essential part of every medical office. With the onset of the electronic revolution, accounting via pen and paper has become an outdated, time-intensive process that is no longer used in most societies. This software is continually evolving, and along with this comes a number of valuable benefits.…
ContinueAdded by Rachel on April 6, 2011 at 5:38am — No Comments
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