Final Guidance Released by FDA for Reprocessing of Reusable Medical Devices

Posted on 20. May, 2015 by .

The U.S. Food and Drug Administration recently announced new actions to enhance the safety of reusable medical devices and address the possible spread of infectious agents between uses. This is especially needed given the recent outbreaks of a “super bug” in several California hospitals where a number of patients were infected with the antibiotic-resistant bacterium [...]

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ISO 13485 Changes: Documenting the Competency Management Program

Posted on 18. May, 2015 by .

Last week I attended the excellent MedCon event at Xavier University, and while every session was informative, I was really intrigued by the session where changes to ISO 13485 were shared. Speakers for the session were Kim Trautman from FDA, Scott Sardeson from 3M, and Bill Brodbeck from STERIS. They all reviewed the proposed changes [...]

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Using a Virus to Fight Cancer

Posted on 11. May, 2015 by .

At Duke University, a brain cancer team is conducting some remarkable research in an effort to fight brain cancer.  The research seems like a radical example of re-thinking and re-framing thoughts and ideas on fighting cancer because it is using a disease-causing virus to fight cancer in the human brain. However, the concept of targeting [...]

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Blended Learning: A Wise Choice for Workforce Skills Readiness

Posted on 07. May, 2015 by .

Many organizations desire a highly trained and skilled workforce. However, this sometimes becomes difficult to maintain while still trying to achieve operational excellence, create value for their customers, expand production and maintain profitability in a volatile market. On-the-job training is not always the most efficient because employees can only learn about what actually happens on [...]

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UDI and the Impact on Accessories

Posted on 06. May, 2015 by .

In our recent webinar on Global UDI Requirements, presented by Linda Chatwin from UL, we received several questions on whether FDA requires that “accessories” have UDI. One of the webinar attendees poised the question this way: “Say your product is a transport ventilator. The ventilator has a gas line, which comes with the device. Let [...]

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A Tale of Two C’s: From Compliance to Competency

Posted on 27. Apr, 2015 by .

Many organizations are able to obtain and maintain high levels of regulatory compliance, but few are able to translate regulatory compliance into a measurement of individual or organizational competence. Few are able to move from mere compliance to the competitive advantage of competency. This lack of movement hampers organizations and impedes progress. Within organizations that [...]

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Concerns About Cosmetics

Posted on 20. Apr, 2015 by .

The FDA has recently turned its attention to cosmetics companies. They are warning cosmetics companies that when claims are made about their products it appears that they have proprieties that would classify them as drugs. Therefore, the cosmetics companies are risking a warning letter…or worse. In fact, the FDA has issued warning letters citing drug [...]

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Medical Research via Your iPhone

Posted on 16. Apr, 2015 by .

Recently, Apple unveiled ResearchKit. This could dramatically alter the landscape of medical research. ResearchKit is an open-source platform designed to help medical researchers expand their study candidate pools and collect more accurate data. The platform, ResearchKit allows participants to enroll in trials directly from an iPhone and submit data automatically, whether entered by hand or [...]

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