Rick Biros, Publisher, MedTech Intelligence
Soapbox

MedTech Intelligence: Better Representing Our Business

By Rick Biros

…very successful Combination Products conference, and you’ll see us leverage content from the conference into the digital publication, including a new section appropriately called Combination Products. Our team has worked…

…very successful Combination Products conference, and you’ll see us leverage content from the conference into the digital publication, including a new section appropriately called Combination Products. Our team has worked…

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

Heigh-Ho, Heigh-Ho, Itā€™s Off to Jail You Go

By Dr. Christopher Joseph Devine

…from http://www.fda.gov/iceci/criminalinvestigations/ucm426475.htm Devine, C. (2011). Devine guidance for complying with the FDA’s quality system regulation –21 CFR, Part 820. Charleston, SC: Amazon. Devine, C. (2013). Devine guidance for managing key…

…from http://www.fda.gov/iceci/criminalinvestigations/ucm426475.htm Devine, C. (2011). Devine guidance for complying with the FDA’s quality system regulation –21 CFR, Part 820. Charleston, SC: Amazon. Devine, C. (2013). Devine guidance for managing key…

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Gain More Control over Your Supply Chain

By Maria Fontanazza

The demands on medical device manufacturers to reduce costs, comply with additional regulations, and ensure product security are putting increased pressure on the supply chain. As companies try to conserve…

The demands on medical device manufacturers to reduce costs, comply with additional regulations, and ensure product security are putting increased pressure on the supply chain. As companies try to conserve…

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Michael Wiklund MedTech Intelligence

Does Your Device Play Well with Others?

By Maria Fontanazza

…device to device within a hospital, or a patient tracking compliance with a therapeutic routine, there is a higher expectation for user interface quality and interoperability. “When considering human factors…

…device to device within a hospital, or a patient tracking compliance with a therapeutic routine, there is a higher expectation for user interface quality and interoperability. “When considering human factors…

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

Establishments Must Calibrate and Maintain their Equipment, Who Knew?

By Dr. Christopher Joseph Devine

…of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA (May 2015). Inspections, Compliance, Enforcement, and Criminal Investigations. AG Industries, Warning Letter. Accessed June…

…of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA (May 2015). Inspections, Compliance, Enforcement, and Criminal Investigations. AG Industries, Warning Letter. Accessed June…

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

Truth in Advertising, FDA Cares

By Dr. Christopher Joseph Devine

…into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k).” Warning Letter – 01 June 2015 “FDA has reviewed your firm’s website, http://www.lifecell.com/health-care-professionals/lifecellproducts/stratticetm-reconstructive-tissue-matrix/, and determined…

…into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k).” Warning Letter – 01 June 2015 “FDA has reviewed your firm’s website, http://www.lifecell.com/health-care-professionals/lifecellproducts/stratticetm-reconstructive-tissue-matrix/, and determined…

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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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