Devine Guidance

Purchasing Controls is not Rocket Science!

By Dr. Christopher Joseph Devine

…(and Dr. D) there is no such thing as minimum compliance; there is no such thing as maximum compliance; there is only compliance! That being said, FDA investigators are not…

…(and Dr. D) there is no such thing as minimum compliance; there is no such thing as maximum compliance; there is only compliance! That being said, FDA investigators are not…

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Medical Devices in Canada: How to Enter the Market

By MedTech Intelligence Staff

…sure how to approach the medical device market in Canada? Packard will be discussing why companies should consider Canada as a critical player in launching new products during the “CMDCAS…

…sure how to approach the medical device market in Canada? Packard will be discussing why companies should consider Canada as a critical player in launching new products during the “CMDCAS…

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Unannounced Inspections by Notified Bodies a ‘Principal Challenge’ for 2015

By MedTech Intelligence Staff

…Product launches (48 percent) and new Medical Device Regulations (45 percent) also pose significant hurdles. Across all UK healthcare and life science firms, respondents reveal lack of investment in compliance…

…Product launches (48 percent) and new Medical Device Regulations (45 percent) also pose significant hurdles. Across all UK healthcare and life science firms, respondents reveal lack of investment in compliance…

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Engineering a Silver Bullet to Fight Infection

As the number of joint replacement surgeries in the U.S. grows, so are concerns about the complications of infection from antibiotic-resistant “superbugs.” Biomedical engineers at NC State University are fighting…

As the number of joint replacement surgeries in the U.S. grows, so are concerns about the complications of infection from antibiotic-resistant “superbugs.” Biomedical engineers at NC State University are fighting…

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Devine Guidance

FDA Issues a Warning Letter with no Plant Inspection! What?

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. (2015, February). FDA.gov Website. Retrieved March24, 2015, from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm438226.htm….

…managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA’s enforcement page. (2015, February). FDA.gov Website. Retrieved March24, 2015, from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm438226.htm….

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Next-Generation Transcatheter Aortic Valve Replacements Will Drive Rapid Market Growth

By MedTech Intelligence Staff

The global market value for transcatheter heart valves will expand at an impressive Compound Annual Growth Rate (CAGR) of 19.7 percent, from almost $881 million in 2013 to around $3.02…

The global market value for transcatheter heart valves will expand at an impressive Compound Annual Growth Rate (CAGR) of 19.7 percent, from almost $881 million in 2013 to around $3.02…

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MEDdesign

Medical Device Development Outsource Selection? Consider a Checklist Manifesto

By Charles Garcia

…skyscraper construction and more. What the settings have in common is they are all highly complex industries, with multiple essential tasks, where errors or ineptitude can be deadly, where safety…

…skyscraper construction and more. What the settings have in common is they are all highly complex industries, with multiple essential tasks, where errors or ineptitude can be deadly, where safety…

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Boston Scientific wins CE Mark and FDA Approval for Thinner, Leadless ICD

By MedTech Intelligence Staff

…earlier than expected FDA approval, and will immediately begin preparations for a mid-year launch of the EMBLEM device in the US.” For more information on the S-ICD System visit www.sicdsystem.com….

…earlier than expected FDA approval, and will immediately begin preparations for a mid-year launch of the EMBLEM device in the US.” For more information on the S-ICD System visit www.sicdsystem.com….

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

What About the Reports?

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. (2015, February). FDA.gov Website. Retrieved March16, 2015, from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm436701.htm….

…managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA’s enforcement page. (2015, February). FDA.gov Website. Retrieved March16, 2015, from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm436701.htm….

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