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Medtronic and IBM, CES

Coming Soon: Medtronic-IBM Watson App to Empower Diabetes Patients

By Maria Fontanazza

…to detect patterns in diabetic patients. Anticipated for release this summer, the app uses Watson’s cognitive computing power to integrate data from Medtronic’s continuous glucose monitoring devices and insulin pumps…

…to detect patterns in diabetic patients. Anticipated for release this summer, the app uses Watson’s cognitive computing power to integrate data from Medtronic’s continuous glucose monitoring devices and insulin pumps…

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Regenerative Medicine

The Steady Progress of Regenerative Medicine

By Maria Fontanazza

Regenerative medicine is most commonly defined as a process or application of a material, device or therapeutic that repairs, replaces or regenerates cells, tissues or organs. The value of the…

Regenerative medicine is most commonly defined as a process or application of a material, device or therapeutic that repairs, replaces or regenerates cells, tissues or organs. The value of the…

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

Receiving Inspection, Who Needs It?

By Dr. Christopher Joseph Devine

…system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (December 22, 2015). Inspections, Compliance, Enforcement, and Criminal Investigations. ARB Medical, LLC. Accessed January 12, 2016. Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm480523.htm…

…system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (December 22, 2015). Inspections, Compliance, Enforcement, and Criminal Investigations. ARB Medical, LLC. Accessed January 12, 2016. Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm480523.htm…

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Sheikh Zayed Instituteā€™s 3rd annual Pediatric Surgical Innovation Symposium

Severely Underserved Pediatrics Market Needs Federal Funding

By Maria Fontanazza

…talk with companies and organizations all the time and thus work with a large network of investors, device companies and small businesses. They all support the argument that, from a…

…talk with companies and organizations all the time and thus work with a large network of investors, device companies and small businesses. They all support the argument that, from a…

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

How Can an Establishment Manufacture Medical Devices Without a DMR?

By Dr. Christopher Joseph Devine

…FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (November 19, 2015). Inspections, Compliance, Enforcement, and Criminal Investigations. Accessed January 3, 2015. Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm473657.htm…

…FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (November 19, 2015). Inspections, Compliance, Enforcement, and Criminal Investigations. Accessed January 3, 2015. Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm473657.htm…

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Design Verification: The Testing Phase

By Roberta Goode

…Journal of Validation Technology, Vol. 9, No. 2, pp. 181. Distribution Dynamics Certified Testing Laboratory. “Package Testing, Product Testing and Materials Testing for the Medical Device Industry”. Retrieved from: http://www.testedandproven.com/…

…Journal of Validation Technology, Vol. 9, No. 2, pp. 181. Distribution Dynamics Certified Testing Laboratory. “Package Testing, Product Testing and Materials Testing for the Medical Device Industry”. Retrieved from: http://www.testedandproven.com/…

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Checkbox

Design Verification: Process Considerations Before Testing

By Roberta Goode

…design verification testing separately from the package design verification testing. This paper suggests a partial combination of functional product and dummy product to demonstrate the package is capable of protecting…

…design verification testing separately from the package design verification testing. This paper suggests a partial combination of functional product and dummy product to demonstrate the package is capable of protecting…

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Design verification in medical devices

Design Verification: Ensure Product Protection throughout the Supply Chain

By Roberta Goode

…process considerations prior to design verification of packaged products. Reference Distribution Dynamics Certified Testing Laboratory. “Package Testing, Product Testing and Materials Testing for the Medical Device Industry”. Retrieved from: http://www.testedandproven.com/…

…process considerations prior to design verification of packaged products. Reference Distribution Dynamics Certified Testing Laboratory. “Package Testing, Product Testing and Materials Testing for the Medical Device Industry”. Retrieved from: http://www.testedandproven.com/…

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FDA

CDRH Wants to Publish at Least 12 Final Guidance Documents in 2016

By MedTech Intelligence Staff

…of Symbols in Labeling 510(k) Modifications Software Modifications 510(k) Third Party Review Program Companion Diagnostics Co-Development Use of Real-World Observational Patient Data to Support Decision Making for Medical Devices UDI…

…of Symbols in Labeling 510(k) Modifications Software Modifications 510(k) Third Party Review Program Companion Diagnostics Co-Development Use of Real-World Observational Patient Data to Support Decision Making for Medical Devices UDI…

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MedTech Predictions for 2016

By Maria Fontanazza

…monitoring companies and early-stage companies that are developing clinical-grade wearables Healthcare spending will continue to dominate healthcare market (United States, Europe and Japan will hold on to 72% of market…

…monitoring companies and early-stage companies that are developing clinical-grade wearables Healthcare spending will continue to dominate healthcare market (United States, Europe and Japan will hold on to 72% of market…

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