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Regulatory Innovation Should Adapt to New Health Economy

…leader. “As a result, companies have a real opportunity to seek out and use consumer feedback to better demonstrate value over existing therapies.” The full report is available at http://www.pwc.com/us/en/health-industries/health-research-institute/….

…leader. “As a result, companies have a real opportunity to seek out and use consumer feedback to better demonstrate value over existing therapies.” The full report is available at http://www.pwc.com/us/en/health-industries/health-research-institute/….

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Done – Medtronic-Covidien Deal

Shares of the new company Medtronic Inc. will debut on Tuesday, January 27, on the New York Stock Exchange. “The culmination of this acquisition marks a significant milestone in our…

Shares of the new company Medtronic Inc. will debut on Tuesday, January 27, on the New York Stock Exchange. “The culmination of this acquisition marks a significant milestone in our…

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How Good is Good Enough? The Importance of Medical Device Performance Specifications

…as the best possible. Assumptions, unknowns and vague goals are what derail development projects. As an example, developing a home thermometer for determining if someone has a fever doesn’t require…

…as the best possible. Assumptions, unknowns and vague goals are what derail development projects. As an example, developing a home thermometer for determining if someone has a fever doesn’t require…

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Why is Biocompatibility Testing of Medical Devices Critical?

Biocompatibility is defined as “compatibility with living tissue or a living system by not being toxic, injurious, or physiologically reactive and not causing immunological rejection.” For medical devices, which come…

Biocompatibility is defined as “compatibility with living tissue or a living system by not being toxic, injurious, or physiologically reactive and not causing immunological rejection.” For medical devices, which come…

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FDA’s Single Audit Program Invites Participants

…the operational program scheduled to begin in 2017. FDA has posted four new documents on the Pilot MDSAP which describes up to date information on how the five participating Regulatory…

…the operational program scheduled to begin in 2017. FDA has posted four new documents on the Pilot MDSAP which describes up to date information on how the five participating Regulatory…

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

Management Review – Internal Audits are Not Rocket Science!

By Dr. Christopher Joseph Devine

…deficiencies, it is also one of the easier requirements to comply with, in Dr. D’s humble opinion. For example, to comply with Section 820.22, an establishment must address all six…

…deficiencies, it is also one of the easier requirements to comply with, in Dr. D’s humble opinion. For example, to comply with Section 820.22, an establishment must address all six…

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J&J Device Sales Fall

…the healthcare giant. The New Brunswick, N.J.-based healthcare giant reported worldwide medical devices sales of $27.5 billion for the full-year 2014 represented a decrease of 3.4 percent versus the prior…

…the healthcare giant. The New Brunswick, N.J.-based healthcare giant reported worldwide medical devices sales of $27.5 billion for the full-year 2014 represented a decrease of 3.4 percent versus the prior…

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Trends to Watch For in Medical Device Industry

…the revenues of medical device manufacturing companies. Many have a concern that this may have negative effects on the development and success of new and potential companies. Wooing government dollars…

…the revenues of medical device manufacturing companies. Many have a concern that this may have negative effects on the development and success of new and potential companies. Wooing government dollars…

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Apps: Fun or Medical Devices?

…for the European market, can be found in the FAQ section related to the implementation of EN 62304:2006 with respect to MDD 93/42/ EEC. For more information, visit http://www.sgs.com/en/Life-Sciences/ Medical-Devices.aspx….

…for the European market, can be found in the FAQ section related to the implementation of EN 62304:2006 with respect to MDD 93/42/ EEC. For more information, visit http://www.sgs.com/en/Life-Sciences/ Medical-Devices.aspx….

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

Management Review – A Really Simple Task

By Dr. Christopher Joseph Devine

…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 January 12, 2015, from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm426559.htm….

…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 January 12, 2015, from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm426559.htm….

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