All Blog Posts Tagged 'for' (69)

Japan is the world's third largest market for medical devices, after the US and Europe. Ironically, many of the world's medical device manufacturers find language barriers for communicating with Japanese regulatory authorities a greater barrier than passing through the regulatory maze! The regulatory filing requirements for medical devices in Japan are…

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Software Validation Process for 21 CFR Part 11 is all about authenticity and integrity of electronic signatures and records. Care should be taken to avoid confusion and get validation right.

The FDA’s Code of Federal Regulations (CFR) is a collection of laws that regulate the various government agencies. Different titles of the CFR govern respective regulated…

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Nanotechnology, a part of Quantum Physics (QP), is growing fast and has myriad uses. Nanotechnology is all about size and self-assembly. While QP deals with subatomic particles and waves; Nano relates to the atomic and molecular level. Atomic behavior and properties get dramatically changed at the Nano level. Of note are properties such as color change due to refraction of light. Gold, packaging and chemistry are some of the well-known areas into which…

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If one were to define validation; it can be considered the deed of testing an item or system for the level or extent to which it complies with a standard that it has to show compliance with.

In the case of computer systems, validation is a major requirement for these regulatory bodies/practices:

o The US FDA

o European Medicines Agency (EMA)

o Good Manufacturing Practices (GMP)

o Good Laboratory Practices (GLP)

o Good Clinical Practices (GCP)

o All the… Continue

The emerging discipline of Hospitals Management Performance Assessments

Over the past few years, Hospitals Management Performance Assessments have begun to gain acceptability and credence in healthcare circles. Hospitals Management Performance Assessments came into being as a result of a conscious effort by advanced countries, mainly European, with sufficient backing from the World Health Organization (WHO) to arrive at some sort of metrics…

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Primary care physicians (PCPs) have been marginalized by Medicare for decades with low reimbursement rates for routine office visits which has led to the 15-20 minute office visit with 10-12 minutes of actual “face time” and a panel of patients that well exceeds 2000. 

Is there a good solution to the Medicare cost and quality issues? Setting aside either the…

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Stress is with us all the time. Issues at work or at home, getting a traffic ticket, the grocery store out of your favorite yogurt. Life has stresses. We can go to the doctor and ask for a pill or we can learn to deal with our stresses effectively without much medication. 

Acute stress is normal and can even be lifesaving – seeing a truck barreling down the road at us. But when stress is chronic it becomes a major cause of ill health. 

Chronic stress builds up when the demands…

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Did you see the stories in the newspapers that TV watching is bad for your health? It is but probably not for the reasons you might think. Certainly being a couch potato is unhealthy and if we sit there for long periods, eating chips, drinking beer and smoking cigarettes, our health will obviously take a turn for the worse. But a new study from Australian researchers observed 8800 adults for over six years and recorded the deaths from heart disease, cancer and all causes. The results were… Continue

From: Kvedar, Joseph Charles,M.D.



To: cc@clymergroup.com



Sent: Wednesday, January 21, 2009 2:47 PM



Subject: Recommendations Sent to Obama Healthcare Team





Dear Conrad,



President Obama and Secretary of Health and Human Services Nominee Tom Daschle asked Americans – and we delivered – to give feedback and recommendations on ways to improve quality and expand access to care.



Per my earlier email, in late 2008, I hosted an… Continue