UPS supply chain logistics

Reducing Risk and Providing Security in Your Global Supply Chain

…quality and regulatory requirements. If companies are leveraging international distributors as a sales channel or contract manufacturers within a new geography, typically either the U.S. commercial services, or logistics and…

…quality and regulatory requirements. If companies are leveraging international distributors as a sales channel or contract manufacturers within a new geography, typically either the U.S. commercial services, or logistics and…

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Combination Products Progressing in Fits and Starts

By Maria Fontanazza

The Office of Combination Products (OCP) was established in 2002 to provide a central source of assistance for issues related to combination products, including navigating the regulations, developing guidance, product…

The Office of Combination Products (OCP) was established in 2002 to provide a central source of assistance for issues related to combination products, including navigating the regulations, developing guidance, product…

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The Miniaturization Power of Micro Molding

…to produce more complex, tighter tolerances, and smaller components. For the past 30 years Accumold has been dedicated to small and micro sized injection molded plastic parts and components. If…

…to produce more complex, tighter tolerances, and smaller components. For the past 30 years Accumold has been dedicated to small and micro sized injection molded plastic parts and components. If…

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Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Decorative Contact Lens are Medical Devices, Say What?

By Dr. Christopher Joseph Devine

…attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA’s enforcement page. (2015, May). FDA.gov Website. Accessed June 08, 2015. Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm448437.htm…

…attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA’s enforcement page. (2015, May). FDA.gov Website. Accessed June 08, 2015. Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm448437.htm…

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Branding, Thought Leadership and Lead Generation = Marketing ROI.

MedTech Intelligence provides unique metrics to support your Advertising, Sponsored Content, Conference Sponsorships & Exhibits ROI. Download our media kit by filling in the form below. Want to speak with…

MedTech Intelligence provides unique metrics to support your Advertising, Sponsored Content, Conference Sponsorships & Exhibits ROI. Download our media kit by filling in the form below. Want to speak with…

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Rosemary Weghorst, Managing Director, Berkeley Research Group LLC

The OIG Work plan: Potential Implications for Medical Device Manufacturers and Suppliers

By Rosemary Weghorst

…Research Group, LLC or its other employees and affiliates. Reference 1. Johnson, D. (2014 November 13).“Hospitals Pocketing Taxpayer Cash for Free Devices.” The Washington Times. Retrieved from: http://www.washingtontimes.com/news/2014/nov/13/golden-hammer-hospitals-pocketing-cash-for-free-de/#ixzz3c16ZylrG    …

…Research Group, LLC or its other employees and affiliates. Reference 1. Johnson, D. (2014 November 13).“Hospitals Pocketing Taxpayer Cash for Free Devices.” The Washington Times. Retrieved from: http://www.washingtontimes.com/news/2014/nov/13/golden-hammer-hospitals-pocketing-cash-for-free-de/#ixzz3c16ZylrG    …

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Hot Topics in Risk Management & Medical Devices

By MedTech Intelligence Staff

…of Goode Compliance International, weighs in on the latest challenges medical device manufacturers are facing in risk management at the 2015 MedTech Intelligence HHE, Risk Assessment, & Recalls Conference in…

…of Goode Compliance International, weighs in on the latest challenges medical device manufacturers are facing in risk management at the 2015 MedTech Intelligence HHE, Risk Assessment, & Recalls Conference in…

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Stringent REACH Standards Make Devices Safer in European Union

By Geoff Kirsner, Yue Yao, Roberta Goode

…of this article addresses the applications of the REACH regulation for both disposable devices and durable medical equipment, although the steps to compliance are common to most medical devices. Compliance…

…of this article addresses the applications of the REACH regulation for both disposable devices and durable medical equipment, although the steps to compliance are common to most medical devices. Compliance…

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Device Meet Drug: Integrating Combination Products Into Your Portfolio

By Anna Julia Hummel, Dr. Tido Eger

…Manufacturing Practices for Combination Products, Final Rule. Accessed May 12, 2015. Retrieved from: http://www.fda.gov/downloads/CombinationProducts/UCM336194.pdf. European Medicines Agency, 2014, Reporting requirements for marketing-authorization holders. Accessed May 12, 2015. Retrieved from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000594.jsp&mid=WC0b01ac058078fbe1….

…Manufacturing Practices for Combination Products, Final Rule. Accessed May 12, 2015. Retrieved from: http://www.fda.gov/downloads/CombinationProducts/UCM336194.pdf. European Medicines Agency, 2014, Reporting requirements for marketing-authorization holders. Accessed May 12, 2015. Retrieved from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000594.jsp&mid=WC0b01ac058078fbe1….

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Maria Fontanazza, Editor-in-Chief, MedTechIntelligence.com

Health Hazard Evaluations: Focus on Complaints and the Patient

By Maria Fontanazza

companies that the level of its investigation should be directly proportional to the complaint. When conducting an HHE, companies need review these product complaints in detail. This includes assessing communications…

companies that the level of its investigation should be directly proportional to the complaint. When conducting an HHE, companies need review these product complaints in detail. This includes assessing communications…

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