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All Blog Posts Tagged 'medical' (159)

Understanding an audit management system

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Added by Adam Fleming on October 19, 2016 at 5:40am — No Comments

Identifying and resolving common issues in FDA Software Validation & Verification

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.…

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Added by Adam Fleming on October 18, 2016 at 5:50am — No Comments

The FDA steps up efforts at bringing about medical device cyber security

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Added by Adam Fleming on October 12, 2016 at 5:41am — No Comments

The FDA code of federal regulations

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…

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Added by Adam Fleming on October 6, 2016 at 5:46am — No Comments

Getting their documentation right is very important for medical device manufacturers

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?…

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Added by Adam Fleming on September 13, 2016 at 6:52am — No Comments

Implementation of Regulatory Aspects of Clinical Research is critical

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…

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Added by Roger Steven on May 27, 2016 at 5:07am — No Comments

What are the Steps involved to Create a Bullet Proof 510(K)

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…

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Added by Adam Fleming on May 25, 2016 at 6:07am — No Comments

Medical Affairs Services: Role in Planning of New Pharmaceutical Product Launch

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…

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Added by Worksure Medpharma on April 6, 2015 at 3:00am — No Comments

Integrative Medicine Part III - Humanism In Medical Care

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…

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Added by Stephen C Schimpff on May 20, 2012 at 7:43am — No Comments

Misconception – Healthcare Reform Will Impact Medical Science

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…

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Added by Stephen C Schimpff on March 7, 2012 at 10:30am — No Comments

The Misconception That American Has The Best Healthcare In The World

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…

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Added by Stephen C Schimpff on February 7, 2012 at 11:25am — No Comments

The Benefits of Medical Billing Software

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.…

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Added by Rachel on April 6, 2011 at 5:38am — No Comments

Real-Time Medical Video Website Uses Identity Verification to Verify Its Members and Combat Fraud

Brandon Winchester, MD, anesthesiologist at Duke University School of Medicine, set out to accomplish the unprecedented in medical education when he and his colleague, Stuart Grant, MB ChB founded DOCSTREAM Inc. The company's proprietary product, DOCSTREAM.COM provides clinicians with a web-based community to upload or watch live or on-demand videos of medical procedures. Because the site is only for medical professionals, the company has incorporated IDology's identity verification solutions… Continue

Added by Jodi Florence on September 14, 2010 at 1:29pm — No Comments

Disruptive Changes Are Coming to the Delivery of Medical Care

The following was an invited post on Harvard Busines Review web site last Friday.



We have grown accustomed to scientific research producing major medical advances such as those I wrote about in The Future of Medicine — Megatrends in Healthcare. But there are now some very disruptive changes coming in how medical care will be delivered by your doctor or hospital.



Some examples:



Team-based care for chronic illness. The combination of an aging population and… Continue

Added by Stephen C Schimpff on April 25, 2010 at 4:42pm — No Comments

Is Technology a Cost Driver or a Cost Saver in Health Care?

The following was an invited post on the Harvard Business Review at http://blogs.hbr.org/cs/2010/04/is_technology_a_cost_driver_or.html



Pharmaceutical, biotechnology, and medical-device and equipment companies have been extremely effective at producing innovations that have created major benefits for medical care. But the cost of new patented drugs and devices (pacemakers, defibrillators, stents,… Continue

Added by Stephen C Schimpff on April 20, 2010 at 3:47pm — 1 Comment

HELP Haiti Earthquake Relief in Health IT Headlines

How health IT will help Haiti - FierceHealthIT



As far as I can tell from news reports, what little healthcare infrastructure Haiti had before last week's earthquake is all but gone now. Yet, some advanced health information technology soon will... Read more...



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Added by Randy Roberson on January 19, 2010 at 7:41pm — 3 Comments

Misconception - Primary care physicians do not deal with the expensive aspects of medical care so they can have little impact on reducing medical expenditures.

Two major reasons for cost escalation are lack of good care coordination of those with complex chronic illnesses and inadequate attention to prevention and screening. PCPs are key to both of these but they have too little time per patient and are not paid for either activity. About 5% of all healthcare expenditures go to PCPs but they can have a major impact on the other 95%, especially with good care coordination of chronic illness and with a focus on prevention.



To fix this, PCPs… Continue

Added by Stephen C Schimpff on January 14, 2010 at 5:19pm — No Comments

Healthcare Reform Misconception - Costs are rising because of the avarice and greed or just unregulated “bad guys

Drug and technology companies, doctors, hospitals, malpractice lawyers and third-party payers/insurers deserve some approbation and bear some responsibility at the margin, but these are not the major reasons why costs are rising. But it seems that politicians, the media and so many others seem to believe what’s convenient rather than what is accurate.



The real culprits are: 1) the poor coordination of care of those with chronic illness resulting in excess visits to specialists,… Continue

Added by Stephen C Schimpff on December 29, 2009 at 11:05am — No Comments

Misconception – Healthcare reform will fundamentally improve how we receive care going forward.

This is also not at all likely except for those who do not now have medical care insurance. For the rest of us, medical care delivery will change but it will change not because of reform but because of some fundamental societal and demographic reasons along with a marked change in the types, severity and chronicity of illnesses that is occurring right now. The combination of an aging population and our non-healthy lifestyles (obesity, poor nutrition, lack of exercise, stress and smoking) are… Continue

Added by Stephen C Schimpff on December 21, 2009 at 2:12pm — No Comments

Video Conference with Becton Dickinson – The Future of Medicine

I was recently invited to present my thoughts on the Future of Medicine, based on my book of the same name, to the worldwide medical affairs group at Becton Dickinson, the giant medical device and diagnostics company headquartered in Franklin Lakes, New Jersey. Their senior vice president for medical affairs, Dr David Durack, requested that I review the basic megatrends developing as a result of the scientific advances from genomics, stem cells transplantation, vaccines, pharmaceuticals,… Continue

Added by Stephen C Schimpff on December 14, 2009 at 9:36am — 1 Comment

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