FDA and CMS Discuss Parallel Review Pilot Program at AdvaMed MedTech Conference

Posted on 20. Oct, 2014 by .

During the AdvaMed MedTech Conference in Chicago (October 6 through 8), I had several conversations with representatives from medtech companies about payer/provider demands. Reimbursement was “top of mind” in several event sessions – in a panel discussion that followed Dr. Margaret Hamburg’s address to attendees, a medical device product developer acknowledged that at this time […]

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What is Apple Healthkit?

Posted on 02. Oct, 2014 by .

It turns out the Apple Watch and iPhone 6 are not the only Apple innovations that have recently surfaced. Apple has created a tool for developers called HealthKit, which allows health and fitness apps to work together and they are hoping it is the beginning of a health revolution. HealthKit is a back-end framework that […]

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Four Things You Should Know About Ebola

Posted on 26. Sep, 2014 by .

With all the news and attention that Ebola is receiving because of the recent outbreak in West Africa, it is worth it to everyone to separate some of the facts from the myths of the disease. One What is Ebola? Ebola is the cause of a viral hemorrhagic fever disease and it is an infectious […]

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Science Fiction Becoming Science Fact

Posted on 22. Sep, 2014 by .

Recently, there has been an increased interest in the creation of products in the Life Science industry that mix traditional Pharmaceuticals and Medical Devices with creative technological tools to create interesting Medical Devices that can save lives, regenerate organs, help people walk and even track information about the habits of a patient.  Sometimes these innovations […]

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Are You Ensuring Supplier Quality?

Posted on 15. Sep, 2014 by .

It is not enough anymore for a Medical Device manufacturing company to simply control what happens within the four walls of its own organization. Worldwide, global regulators are starting to require companies to control supply chain procurement, manufacturing and product distribution. According to Cerulean Associates, there were 126 FDA 483 observations of supplier control deficiencies […]

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Labeling Errors Can Be Costly

Posted on 27. Aug, 2014 by .

Two recent recalls due to mislabeling has called attention to the importance of proper container packaging and carton labeling of pharmaceuticals. One recall was initiated by a manufacturer of blood glucose test strips; they voluntarily conducted a Class 1 nationwide recall of their blood glucose test strips due to a labeling error that omitted the strips’ […]

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Is Your Sales Pitch on Target?

Posted on 14. Aug, 2014 by .

Recently, the FDA admonished a Pharmaceutical organization for a telephone sales pitch about its attention deficit hyperactivity disorder drug  that omitted critical risk and dosing information.  Additionally, the telemarketing script allegedly didn’t mention warnings, precautions and adverse events connected with the drug, says an untitled letter released by the FDA’s Office of Prescription Drug Promotion (OPDP). […]

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ComplianceWire iOS Learner App for iPad

Posted on 05. Aug, 2014 by .

Recently UL EduNeering released the ComplianceWire Learner App on the Apple App Store for iPad. This App will allow users to use ComplianceWire’s functionality including CICS, quizzes, exams, forms, electronic signatures, EduFlex courses and AICC courses.  Here’s more on what you need to know about the new ComplianceWire Learner App: What is the ComplianceWire Learner App? […]

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