Emmanuel Garnier, Simmons & Simmons LLP

Medtech Companies Must Prepare for Brexit Now

By Emmanuel Garnier

Preparing for Brexit is not just a matter for EU and national authorities, but also for private parties, notably life sciences and medtech companies throughout the world. All companies must…

Preparing for Brexit is not just a matter for EU and national authorities, but also for private parties, notably life sciences and medtech companies throughout the world. All companies must…

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

Seriously, No Audits Performed Since 2015?

By Dr. Christopher Joseph Devine

…key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (January 2018). Inspections, Compliance, Enforcement, and Criminal Investigations. Light Age, Inc. Accessed…

…key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (January 2018). Inspections, Compliance, Enforcement, and Criminal Investigations. Light Age, Inc. Accessed…

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Nathan Muller, StarFish Medical
MEDdesign

Biomaterials: Overview and Design Considerations

By Nathan MĆ¼ller

…synthesized or derived from natural sources, and be made up of metallic, polymeric, ceramic, or a composite of these materials. Contrary to their name, they do not need to be…

…synthesized or derived from natural sources, and be made up of metallic, polymeric, ceramic, or a composite of these materials. Contrary to their name, they do not need to be…

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FDA

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

By MedTech Intelligence Staff

…February 2, and that number fell to 24,578 on February 19. Companies may be removed from the active database if they do not renew (or properly renew) their annual registration…

…February 2, and that number fell to 24,578 on February 19. Companies may be removed from the active database if they do not renew (or properly renew) their annual registration…

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Stephanie Domas, MedSec

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

By Maria Fontanazza

…device type; it’s more about if the device is running commodity software, such as devices that are based on Windows. Medical devices that are running commodity software are susceptible to…

…device type; it’s more about if the device is running commodity software, such as devices that are based on Windows. Medical devices that are running commodity software are susceptible to…

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3D printing

Medical 3-D Printing Making Rapid Strides in Asia

By Ames Gross

…Tokyo, whose U.S.-based subsidiary, Matheson, focuses on medical, specialty and electronic gas equipment. Asian 3-D Medical Printing Companies Companies based in Asian countries such as South Korea and Taiwan are…

…Tokyo, whose U.S.-based subsidiary, Matheson, focuses on medical, specialty and electronic gas equipment. Asian 3-D Medical Printing Companies Companies based in Asian countries such as South Korea and Taiwan are…

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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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