FDA

Report: FDA Removed More Than 2500 Medical Device Establishments from Database

By MedTech Intelligence Staff

…active database if they do not renew (or properly renew) their annual registration with the agency. Device companies must renew between October 1 and December 31 on an annual basis….

…active database if they do not renew (or properly renew) their annual registration with the agency. Device companies must renew between October 1 and December 31 on an annual basis….

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Stephanie Domas, MedSec

Medtech Cybersecurity State Not All Doom and Gloom, But Long Way to Go

By Maria Fontanazza

…a challenging task for smaller organizations, especially in the device industry. In a Q&A with MedTech Intelligence, Stephanie Domas, vice president of research at MedSec, LLC, a cybersecurity research firm…

…a challenging task for smaller organizations, especially in the device industry. In a Q&A with MedTech Intelligence, Stephanie Domas, vice president of research at MedSec, LLC, a cybersecurity research firm…

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3D printing

Medical 3-D Printing Making Rapid Strides in Asia

By Ames Gross

…that it would launch a new evaluation system, called the New Medical Technology Evaluation Committee. This body is made up of medical doctors with the aim of speeding up the…

…that it would launch a new evaluation system, called the New Medical Technology Evaluation Committee. This body is made up of medical doctors with the aim of speeding up the…

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Laura Osifchin, Gene Nichols

How to Drive Change and Compliance in a Cost-Reduction Environment

By Gene Nichols, Laura Osifchin

…Ashvin, S. (July 2015). Changing Change Management. McKinsey & Company. Retrieved from https://www.mckinsey.com/global-themes/leadership/changing-change-management. What Drives Employee Engagement and Why It Matters. (2012). Dale Carnegie Training White Paper. Retrieved from https://www.dalecarnegie.com/assets/1/7/driveengagement_101612_wp.pdf….

…Ashvin, S. (July 2015). Changing Change Management. McKinsey & Company. Retrieved from https://www.mckinsey.com/global-themes/leadership/changing-change-management. What Drives Employee Engagement and Why It Matters. (2012). Dale Carnegie Training White Paper. Retrieved from https://www.dalecarnegie.com/assets/1/7/driveengagement_101612_wp.pdf….

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

What, No Training?

By Dr. Christopher Joseph Devine

…C. (2013). Devine guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (January 2018). Inspections, Compliance, Enforcement, and…

…C. (2013). Devine guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (January 2018). Inspections, Compliance, Enforcement, and…

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Medical device recall

Medical Device Recalls Down Nearly 10%

By MedTech Intelligence Staff

Register to attend the Medical Device Recalls conference, May 14–15, 2018 in Washington, DC. Or attend virtually. Learn moreSoftware, mislabeling, quality and manufacturing defects were among the top reasons for

Register to attend the Medical Device Recalls conference, May 14–15, 2018 in Washington, DC. Or attend virtually. Learn moreSoftware, mislabeling, quality and manufacturing defects were among the top reasons for

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gavel

Medical Device Software & Products Liability: Interoperability (Part III)

By Sara E. Dyson, Esq.

…or combined with products created by several other manufacturers. In other instances, companies set out to create interoperable products in collaboration with partner-manufacturers. For example, consider the relationship between Stryker…

…or combined with products created by several other manufacturers. In other instances, companies set out to create interoperable products in collaboration with partner-manufacturers. For example, consider the relationship between Stryker…

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Alert

Pentax Medical Recalls Certain Duodenoscopes

By MedTech Intelligence Staff

…facilities acknowledge Pentax Medical’s correction and removal notification, and identify all affect products in their facility. More information is available in an updated safety communication on FDA’s website. https://medtechintelligence.com/news_article/why-duodenoscopes-are-so-tough-to-clean/  …

…facilities acknowledge Pentax Medical’s correction and removal notification, and identify all affect products in their facility. More information is available in an updated safety communication on FDA’s website. https://medtechintelligence.com/news_article/why-duodenoscopes-are-so-tough-to-clean/  …

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RJ Palmero, Innovative Publishing

RJ Palermo Joins Innovative Publishing Company Team

By MedTech Intelligence Staff

RJ Palermo has joined Innovative Publishing Co. (IPC) as Director of Sales – Events. In this newly created position at IPC, RJ will be managing the business development activities of…

RJ Palermo has joined Innovative Publishing Co. (IPC) as Director of Sales – Events. In this newly created position at IPC, RJ will be managing the business development activities of…

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