Evidence Partners

How Literature Review Automation Improves CER and PER Program Management

By Marc Dufresne

…across the company. But the biggest benefit is time: Research teams spend less time completing logistical tasks such as data entry and more time using their expertise to complete a…

…across the company. But the biggest benefit is time: Research teams spend less time completing logistical tasks such as data entry and more time using their expertise to complete a…

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Tara Lysechko, Starfish Medical

Does Your Class II Device Qualify for a 510(k) Premarket Notification Exemption?

…article provides background and resources to help determine if your Class II device qualifies for a 510(k) premarket notification exemption. On July 22, 2020, the FDA published its latest order…

…article provides background and resources to help determine if your Class II device qualifies for a 510(k) premarket notification exemption. On July 22, 2020, the FDA published its latest order…

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Aleksey Baldygin, KRUSS

Ask the Expert: Surface Science for Superior Biocompatibility and Well-formed Bonds

By Aleksey Baldygin, Ph.D.

…if materials are compatible with the body and if a device’s components will bond together. Surface science sheds light on certain properties to help interpret and precisely control these behaviors,…

…if materials are compatible with the body and if a device’s components will bond together. Surface science sheds light on certain properties to help interpret and precisely control these behaviors,…

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Telemedicine Mobile App Cybersecurity Infographic

Securing devices so that clinicians and patients connect without fear.

By Irdeto

If mobile medical app cybersecurity is not well implemented, there can be several negative consequences. How can you protect your mobile medical application from hackers? Download the infographic to learn…

If mobile medical app cybersecurity is not well implemented, there can be several negative consequences. How can you protect your mobile medical application from hackers? Download the infographic to learn…

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Eli Lilly

Teaming Up to Deliver Game-Changing Solutions for People with Chronic Disease

By Jeff Andrews

…We’ve teamed up with other companies who share Lilly’s core value of making patients’ lives better. We’re combining our 100-year history of expertise in diabetes management, insulin pen development and…

…We’ve teamed up with other companies who share Lilly’s core value of making patients’ lives better. We’re combining our 100-year history of expertise in diabetes management, insulin pen development and…

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Ale Brown, Kirke Management
Soapbox

Creating an Effective and HIPAA-Compliant Data Management Strategy

By Ale Brown

…because a regulation requires it, but because it is good from a business management perspective. The following are key components to a data management strategy for medical device companies to…

…because a regulation requires it, but because it is good from a business management perspective. The following are key components to a data management strategy for medical device companies to…

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David DeRam, GreenlightGuru
Soapbox

Why Paper-Based Systems No Longer Make the Cut

By Alex Condon, Chris Byers, David DeRam

…with both regulations and increasing levels of competition. Meanwhile, technology is rapidly changing the way medical device companies manage their quality systems. There is simply too much at stake to…

…with both regulations and increasing levels of competition. Meanwhile, technology is rapidly changing the way medical device companies manage their quality systems. There is simply too much at stake to…

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European Union Flag

Corrections, Corrective Actions, and Preventive Actions: Effectively Handling Nonconformances in Compliance with the EU MDR

By Bryan Brosseau

…of nonconformance even when one has not yet occurred? Complaint Investigations: Even where a complaint investigation revealed there was no non-conformance, did the investigation reveal an opportunity for such a…

…of nonconformance even when one has not yet occurred? Complaint Investigations: Even where a complaint investigation revealed there was no non-conformance, did the investigation reveal an opportunity for such a…

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

Device History Records and Rework

By Dr. Christopher Joseph Devine

…– 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (August 2018). Inspections, Compliance, Enforcement, and Criminal Investigations. Medtronic Puerto Rico Operations Co. Accessed October 1, 2018. Retrieved from https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm619206.htm…

…– 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (August 2018). Inspections, Compliance, Enforcement, and Criminal Investigations. Medtronic Puerto Rico Operations Co. Accessed October 1, 2018. Retrieved from https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm619206.htm…

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Technology hazards in hospirals, ECRI

For Second Year in a Row, Cybersecurity Issue Tops ECRI Health Tech Hazards List

By MedTech Intelligence Staff

…or rendering it unusable, or hijacking computing resources for other purposes, such as to generate cryptocurrency,” the report states. The following is the 2019 list (Download the hazards list for…

…or rendering it unusable, or hijacking computing resources for other purposes, such as to generate cryptocurrency,” the report states. The following is the 2019 list (Download the hazards list for…

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