Cybersecurity

New Program Prepares Companies for Medtech Cyberattacks

By Maria Fontanazza

…medical device companies face as more products require connectivity within the home and the hospital setting. A program recently launched by UL aims to help device manufacturers mitigate such security…

…medical device companies face as more products require connectivity within the home and the hospital setting. A program recently launched by UL aims to help device manufacturers mitigate such security…

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Mobile Health in Asia: Making the Most of Smartphone Technology

By Ames Gross

The development of low-cost, high-quality smartphones is changing the way that patients and doctors communicate with one another. This new trend is the result of medical device companies teaming up…

The development of low-cost, high-quality smartphones is changing the way that patients and doctors communicate with one another. This new trend is the result of medical device companies teaming up…

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FDA

FDA Releases Draft Guidance on 3-D Printed Devices

By MedTech Intelligence Staff

…as a mechanism by which the Agency can share initial thoughts regarding emerging technologies that are likely to be of public health importance early in product development.” Comments can be…

…as a mechanism by which the Agency can share initial thoughts regarding emerging technologies that are likely to be of public health importance early in product development.” Comments can be…

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Do Robots Improve Surgical Techniques?

By Maria Fontanazza

…using STAR technology (yet the researchers said that this is comparable to the average time to complete laparoscopic anastomosis at 30 to 90 minutes). According to Peter Kim, vice president…

…using STAR technology (yet the researchers said that this is comparable to the average time to complete laparoscopic anastomosis at 30 to 90 minutes). According to Peter Kim, vice president…

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Eric Soederberg, Sunrise Labs

Device Design: Never Underestimate Connectivity

By Maria Fontanazza

…when the device itself is compromised, but the device could also be used as a conduit into the hospital’s network and put the hospital’s network at risk for compromise by…

…when the device itself is compromised, but the device could also be used as a conduit into the hospital’s network and put the hospital’s network at risk for compromise by…

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

Failure of Management with Executive Responsibility

By Dr. Christopher Joseph Devine

…for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (March 2016). Inspections, Compliance, Enforcement, and Criminal Investigations. Grams Medical,…

…for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (March 2016). Inspections, Compliance, Enforcement, and Criminal Investigations. Grams Medical,…

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Cook Medical Recalls More than 4 Million Catheters

By MedTech Intelligence Staff

Yesterday FDA released information about a voluntary recall of Cook Medical’s catheters with Beacon Tip technology. On April 15, the company recalled 4,146,309 catheters that were found to exhibit degradation…

Yesterday FDA released information about a voluntary recall of Cook Medical’s catheters with Beacon Tip technology. On April 15, the company recalled 4,146,309 catheters that were found to exhibit degradation…

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

Statistical Techniques: Zero for 11

By Dr. Christopher Joseph Devine

…quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (March 2016). Inspections, Compliance, Enforcement, and Criminal Investigations. DMP ,Ltd. Accessed April 13, 2016. Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm497069.htm….

…quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (March 2016). Inspections, Compliance, Enforcement, and Criminal Investigations. DMP ,Ltd. Accessed April 13, 2016. Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm497069.htm….

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Parminder Kalle, Maetrics

Eight Steps to Post-Market Surveillance Compliance

By Parminder Kalle

communication open between customers who have already filed a complaint and the business in order to garner all necessary information about relevant complaints and understand if there is any scope…

communication open between customers who have already filed a complaint and the business in order to garner all necessary information about relevant complaints and understand if there is any scope…

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Medical device recall

CDRH, Industry to Discuss Collaboration on HHE and Recalls

By MedTech Intelligence Staff

…the key players in the process? What are the best practices for communication, especially on an external level? CDRH officials, including Ron Brown, director of the recall branch at the…

…the key players in the process? What are the best practices for communication, especially on an external level? CDRH officials, including Ron Brown, director of the recall branch at the…

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