On September 6, 2017, FDA finalized a guidance document entitled “Design Considerations and Pre-Market Submission Recommendations for Interoperable Medical Devices” (“Final Guidance”). In the Final Guidance, the agency outlines design considerations for manufacturers when developing…
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Added by John Robinson on September 20, 2017 at 6:32am —
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Sens. Lindsey Graham of South Carolina and Bill Cassidy of Louisiana have drafted the latest Republican attempt to repeal Obamacare. The bill would overhaul or eliminate major sections of the health care law, including its subsidized insurance coverage and Medicaid expansion. Instead, states would receive block grants, or a lump sum of money from the federal…
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Added by John Robinson on September 20, 2017 at 6:29am —
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In late 2016, the FDA published the revised the Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, Guidance for Industry. The aim of this revision is to address Good Manufacturing Practices (GMPs) for a Quality Management System for Active Pharmaceutical Ingredients (API’s). Another of its aims is to help companies ensure that they meet the requirements of API quality and purity characteristics. While replacing Q7A Good Manufacturing Practice…
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Added by Adam Fleming on September 20, 2017 at 6:27am —
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About Nitinol-based Medical Devices
Nitinol-based medical devices are made of nitinol, an alloy of nickel and titanium. The use of nitinol-based stents and guidewires has improved procedural outcome. The nitinol alloys are corrosion resistant and are highly accepted in the medical device industry. The global medical devices market has been growing extensively over the years. With increasing investment in research and development (R&D) for manufacturing…
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Added by Adam Fleming on September 19, 2017 at 6:05am —
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One in every seven men in the United States will get prostate cancer, making it the second most common type, after skin cancer, for American men. It tends to be a slow-growing disease, but can sprint to life-threatening severity if detected too late. Screening for prostate cancer can yield false-positive findings, but those most at risk for the disease—men whose father or a brother had prostate cancer, African American men, overweight men, and those in their 60s and 70s who are in good…
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Added by John Robinson on September 19, 2017 at 5:54am —
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Hermetic Implantable Packaging and Connectors for Medical Components
PA&E works with leading medical implant designers to advance integration and performance for hermetic implantable packaging and connectors in one of the most unique and critical environments known: the human body.
PA&E has created proprietary materials and encapsulations with hermetic seals that enable implantable medical…
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Added by John Robinson on September 19, 2017 at 5:51am —
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And the damage to the heart and blood vessels can occur in youth at blood pressure levels that are below the clinical definition of hypertension in youth.
High blood pressure in youth is defined differently than it is in adults. In childhood, high blood pressure is based on percentiles, rather than blood pressure level. Researchers looked at…
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Added by John Robinson on September 18, 2017 at 7:45am —
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After watching his mother die from meningitis in a nationwide outbreak caused by contaminated steroids, Scott Shaw is determined to make sure something like that never happens again.
A stiff punishment for the Massachusetts pharmacist Shaw believes is partially responsible…
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Added by John Robinson on September 18, 2017 at 7:42am —
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For people on a job hunt, the reason for not offering one is almost invariably the same: You lack experience. How do you convince the organization that one can gain no experience unless one has a job? This is a typical chicken and egg conundrum: You are not given a job because you have no experience, and you have no experience because you don't get a…
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Added by Roger Steven on September 18, 2017 at 6:52am —
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Some of the functions of medical device manufacturers include:
o Analyzing complaints
o Processing data
o Evaluating nonconformances
o Utilizing other quality data sources.
The main purpose of this analysis, done using appropriate statistical methodology, under §820.100, is to identify the cause of nonconforming products and other quality problems. Time series analysis is one such family of these tools. Also called trending analysis,…
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Added by Adam Fleming on September 18, 2017 at 6:49am —
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Disasters, which can ultimately lead to a data breach, come in various forms – natural, man-made and technical. HIPAA, the HITECH Act, the Federal Trade Commission and the Securities and Exchange Commission are just a handful of entities requiring that the confidentiality, integrity and availability of the sensitive information (e.g., protected health information (PHI) and personally identifiable information (PII)) remain intact. Although federal HIPAA has distinct…
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Added by John Robinson on September 15, 2017 at 6:46am —
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The position of the corporate controller, or company controller, has become an important one in companies today. This is a role that has come into being following the evolution of the corporate setup, which has brought with it many changes. The corporate controller has come into existence because of these changes.
In simple terms, the corporate controller is one who can be defined as the chief accounting officer. She is to accounting what the chief…
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Added by John Robinson on September 15, 2017 at 6:43am —
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What, in your estimate, is the cost of taking up a career in compliance? Thousands of dollars? Hundreds? Well, none of these! If you are considering a career in compliance, join our $10 training online! Yes, $10 is all that it costs for you to start a career in compliance!
Who is offering this monstrous offer, and why? Let us explore this a bit for you: GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, has come up with an…
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Added by John Robinson on September 15, 2017 at 6:06am —
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Obesity is one of the biggest causes of non-communicable, lifestyle diseases today. According to the World Health Organisation, close to 1.9 billion adults were obese in the year 2014. Around 2.8 million people die due to some complications associated with obesity every year. A recent study published in the Journal of the American College of Cardiology notes that obese people who may otherwise be healthy and free from ailments like diabetes, hypertension, et cetera may still run at…
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Added by John Robinson on September 13, 2017 at 6:45am —
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The core of successful operation by a drug maker is laboratory testing. current Good Manufacturing Practices (cGMP) regulations require a drug manufacturer to use laboratory testing as a tool to validate that everything that goes into a laboratory product, such as in-process materials, finished materials, and containers adhere to set specifications. When all these are done, a major challenge for laboratories is in how to deal with a test that shows an…
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Added by Adam Fleming on September 12, 2017 at 5:59am —
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There are not enough NHS psychiatrists in some parts of the UK and more should be recruited to improve care, says the Royal College of Psychiatrists.
In Scotland, there are 10 consultant psychiatrists per 100,000 people – but only eight for the same number in England and Northern Ireland, and just six in Wales.
London’s tally…
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Added by John Robinson on September 11, 2017 at 6:04am —
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If as organizations in the regulated industries, you had lost hope of how to overcome regulatory and compliance pain points, all that you need to do is register for GlobalCompliancePanel’s $10 training!
Yes, $10 is all it costs to overcome regulatory and compliance pain points for companies. Just register for GlobalCompliancePanel’s $10 training, and you are done. How does a company every…
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Added by John Robinson on September 7, 2017 at 6:39am —
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Earlier this year, Gartner released a forecast for the Internet of Things (IoT)predicting that 8.4 billion connected things will be in use worldwide in 2017 and that total spending on endpoints and services will reach almost $2 trillion this year. This forecast is certainly encouraging, but due to the prevalence and influence of the Internet of Things in almost all business arenas, it’s not…
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Added by John Robinson on September 6, 2017 at 6:53am —
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Medical device training courses for just $10. This is not something you get to hear all that often. Or, is it some kind of joke that is being made to entice the regulatory professional in the medical devices arena? Well, none of these thoughts is true. Medical device training courses for just $10 is a very real offer from GlobalCompliancePanel, a leading provider of…
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Added by John Robinson on August 29, 2017 at 6:50am —
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Used to paying over $250 for a high quality healthcare webinar from a leading expert on the topic from a reputable provider of professional trainings? Let us change your habit! You no longer have to pay this much. So, how much do you think you need to be paying for top healthcare webinars? $200? $150? $100? None of these. All that you have to pay for a top healthcare…
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Added by John Robinson on August 28, 2017 at 6:24am —
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