Explaining IVD Classification Issues

Explaining IVD Classification Issues

By bsi

To comply with the Regulation on in vitro diagnostic medical devices (2017/746) (IVDR) manufacturers must classify their in vitro diagnostic (IVD) devices in accordance with the rules set out in…

To comply with the Regulation on in vitro diagnostic medical devices (2017/746) (IVDR) manufacturers must classify their in vitro diagnostic (IVD) devices in accordance with the rules set out in…

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Tara Lysechko, Starfish Medical

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

…information provided in this article to guide your research, but check with the FDA or use an accredited consultant to make a final determination for your medical device regulatory strategy….

…information provided in this article to guide your research, but check with the FDA or use an accredited consultant to make a final determination for your medical device regulatory strategy….

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Telemedicine Cybersecurity Report: Android Patient-Facing Mobile Apps

Telemedicine Cybersecurity Report: Android Patient-Facing Mobile Apps

By Irdeto

In this new whitepaper, Irdeto identified five B2C patient-facing Android telemedicine mobile apps that offer both synchronous and asynchronous virtual visit experiences to US consumers and are downloadable via Google…

In this new whitepaper, Irdeto identified five B2C patient-facing Android telemedicine mobile apps that offer both synchronous and asynchronous virtual visit experiences to US consumers and are downloadable via Google…

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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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Evidera - Trends in Medical Device Purchasing

Trends in Medical Device Purchasing, Evaluation of Value, and Advice for Manufacturers

By Evidera

Gone are the days of selling med tech products to surgeons and physicians based on relationships alone. Today, surgeons must convince hospitals that a new product provides clinical and economic…

Gone are the days of selling med tech products to surgeons and physicians based on relationships alone. Today, surgeons must convince hospitals that a new product provides clinical and economic…

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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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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

…were manufactured on the new fixtures by multiple employees and inspected for compliance to the specification. Employees were retrained on the use of the new fixture and the new inspection…

…were manufactured on the new fixtures by multiple employees and inspected for compliance to the specification. Employees were retrained on the use of the new fixture and the new inspection…

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