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Medtronic Posts Higher-Than-Expected Q3 Profits

By MedTech Intelligence Staff

Medtronic Plc, which recently completed the $49.9 billion acquisition of Ireland-based Covidien Plc, posted better-than-expected third-quarter profits, driven by solid growth in its cardiac and vascular business. The company’s heart…

Medtronic Plc, which recently completed the $49.9 billion acquisition of Ireland-based Covidien Plc, posted better-than-expected third-quarter profits, driven by solid growth in its cardiac and vascular business. The company’s heart…

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

Packaging Modalities Must Be Appropriately Validated

By Dr. Christopher Joseph Devine

…820 Compliance. Charleston, SC: Amazon. DuPont™ Tyvek® Medical Packaging Transition Project (MPTP). (2015, February). http://www.dupont.com/products-and-services/packaging-materials-solutions/pharmaceutical-packaging/brands/tyvek-sterile-packaging/uses-and-applications/tyvek-medical-packaging-transition.html FDA’s enforcement page. (2014, December). FDA.gov Website. Retrieved February 16, 2015, from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm433090.htm ISO 11607-1…

…820 Compliance. Charleston, SC: Amazon. DuPont™ Tyvek® Medical Packaging Transition Project (MPTP). (2015, February). http://www.dupont.com/products-and-services/packaging-materials-solutions/pharmaceutical-packaging/brands/tyvek-sterile-packaging/uses-and-applications/tyvek-medical-packaging-transition.html FDA’s enforcement page. (2014, December). FDA.gov Website. Retrieved February 16, 2015, from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm433090.htm ISO 11607-1…

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

No Established Procedure for Servicing will Result in a Form 483 Observation!

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, December). FDA.gov Website. Retrieved January 31, 2015, from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm429201.htm….

…key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA’s enforcement page. (2014, December). FDA.gov Website. Retrieved January 31, 2015, from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm429201.htm….

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

No Quality Policy and No Quality Objectives, No Kidding?

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, December). FDA.gov Website. Retrieved January 31, 2015, from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm429201.htm….

…key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA’s enforcement page. (2014, December). FDA.gov Website. Retrieved January 31, 2015, from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm429201.htm….

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Preparing for Unannounced Audits

…audit? EU Commission Recommendation 2013/473/EU As most people will now be aware, all medical device manufacturers certified under one or more of the EU Directives on medical devices (i.e. 90/385/EEC,…

…audit? EU Commission Recommendation 2013/473/EU As most people will now be aware, all medical device manufacturers certified under one or more of the EU Directives on medical devices (i.e. 90/385/EEC,…

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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 ā€“ 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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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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Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Management Review ā€“ Internal Audits are Not Rocket Science!

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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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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