Won’t Follow M&A Trend – Says Smith & Nephew CEO

…conference on healthcare, as per a Reuters news story. Last last year, Stryker Corp was rumored to be bidding for Smith & Nephew, Europe’s largest maker of artificial joints. According…

…conference on healthcare, as per a Reuters news story. Last last year, Stryker Corp was rumored to be bidding for Smith & Nephew, Europe’s largest maker of artificial joints. According…

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The Key to Successfully Selling Medical Devices in China and Japan – Good Distributors

By Ames Gross

…Because many Chinese distributors operate on a provincial basis, Western medical device companies often partner with multiple Chinese distributors in order to obtain national coverage. In late 2012 Aerocrine (Sweden)…

…Because many Chinese distributors operate on a provincial basis, Western medical device companies often partner with multiple Chinese distributors in order to obtain national coverage. In late 2012 Aerocrine (Sweden)…

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Making the News for All the Wrong Reasons

Recently, several Medical Device companies have been making the news for some record settlements, recalls and court cases: Stryker, the artificial hip implant company, announced that it has reached a…

Recently, several Medical Device companies have been making the news for some record settlements, recalls and court cases: Stryker, the artificial hip implant company, announced that it has reached a…

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The Proposal: Marrying the Right Labeling Partner

By Darren Atkinson

…one of the most comprehensive and impactful processes in any manufacturing organization. A former CEO at one major multinational life science company once famously argued that when he examined the…

…one of the most comprehensive and impactful processes in any manufacturing organization. A former CEO at one major multinational life science company once famously argued that when he examined the…

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

Time, and Choosing Wisely

By Dr. Christopher Joseph Devine

…is no such thing as maximum compliance, there is no such thing as minimum compliance, there is only compliance!” Once device establishments figure out the compliance piece, life in a…

…is no such thing as maximum compliance, there is no such thing as minimum compliance, there is only compliance!” Once device establishments figure out the compliance piece, life in a…

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Choosing the Right Solution for Issue Management and CAPA

…In today’s competitive environment, companies are challenged to reduce product and operating costs while improving on product quality to help distinguish them in the marketplace. Every effort must be made…

…In today’s competitive environment, companies are challenged to reduce product and operating costs while improving on product quality to help distinguish them in the marketplace. Every effort must be made…

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

Ten Days and the Clock is Ticking

By Dr. Christopher Joseph Devine

…managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA’s enforcement page. (2014, November). FDA.gov Website. Retrieved December 16, 2014, http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm423254.htm….

…managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA’s enforcement page. (2014, November). FDA.gov Website. Retrieved December 16, 2014, http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm423254.htm….

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3D Printing and the (New) Product Development Road Map

It’s clear that 3D printers have become the most powerful new tool in the product development process; widely used in industries ranging from automotive to medical; facilitating prototyping and manufacturing…

It’s clear that 3D printers have become the most powerful new tool in the product development process; widely used in industries ranging from automotive to medical; facilitating prototyping and manufacturing…

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Managing Pain Points in the Healthcare Supply Chain

…implementing these strategies to increase competitiveness, companies are slow to act. Global market expansion: Over the past 18 months, 65 percent have tapped into new global markets to expand their…

…implementing these strategies to increase competitiveness, companies are slow to act. Global market expansion: Over the past 18 months, 65 percent have tapped into new global markets to expand their…

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