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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Rosemary Weghorst, Managing Director, Berkeley Research Group LLC

The OIG Work plan: Potential Implications for Medical Device Manufacturers and Suppliers

By Rosemary Weghorst

…year will be the OIG’s review of how the competitive bidding process impacts access to durable medical equipment. Concerns have been raised that competitive bidding in certain areas could limit…

…year will be the OIG’s review of how the competitive bidding process impacts access to durable medical equipment. Concerns have been raised that competitive bidding in certain areas could limit…

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Hot Topics in Risk Management & Medical Devices

By MedTech Intelligence Staff

…of Goode Compliance International, weighs in on the latest challenges medical device manufacturers are facing in risk management at the 2015 MedTech Intelligence HHE, Risk Assessment, & Recalls Conference in…

…of Goode Compliance International, weighs in on the latest challenges medical device manufacturers are facing in risk management at the 2015 MedTech Intelligence HHE, Risk Assessment, & Recalls Conference in…

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Device Meet Drug: Integrating Combination Products Into Your Portfolio

By Anna Julia Hummel, Dr. Tido Eger

Combination products are a major growth area for life science companies and in the future, many companies have or will have combination products in their portfolio. Combination products are made…

Combination products are a major growth area for life science companies and in the future, many companies have or will have combination products in their portfolio. Combination products are made…

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

FDA & Duodenoscopes ā€“ The Panel

By Dr. Christopher Joseph Devine

…Retrieved from http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/Gastroenterology-UrologyDevicesPanel/UCM447407.pdf Code of Federal Regulation. (2014, April) Title 21 Part 820: Quality system regulation. Washington, D.C.: U.S. Government Printing Office. Devine, C. (2011). Devine guidance for complying with…

…Retrieved from http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/Gastroenterology-UrologyDevicesPanel/UCM447407.pdf Code of Federal Regulation. (2014, April) Title 21 Part 820: Quality system regulation. Washington, D.C.: U.S. Government Printing Office. Devine, C. (2011). Devine guidance for complying with…

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Devine Guidance

Bigler v. Olympus & Virginia Mason Medical Center

By Dr. Christopher Joseph Devine

system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. Terhune, C. (2015, May). Superbug outbreaks: Seattle hospital accuses Olympus of hiding scope defects. Retrieved may 19, 2015, from http://www.latimes.com/business/la-fi-olympus-scope-seattle-20150512-story.html…

system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. Terhune, C. (2015, May). Superbug outbreaks: Seattle hospital accuses Olympus of hiding scope defects. Retrieved may 19, 2015, from http://www.latimes.com/business/la-fi-olympus-scope-seattle-20150512-story.html…

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