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Combination Products

Dan Fowler, WuXi AppTec
November 11, 2020
Dan Fowler, WuXi AppTec
MEDdesign

Designing the Worst-Case Test to Get Best Case Results

By Dan Fowler
No Comments

To avoid delays in timelines, companies should develop IFU cleaning instructions with the worst-case clinical use and contamination method in mind.

Continue reading →

Lise Stevens, Iperion
November 4, 2020
Lise Stevens, Iperion
Soapbox

How the COVID-19 Response Is Revealing Potential of IDMP

By Lise Stevens
No Comments

The pandemic is helping realize the potential of ISO IDMP data standards in relation to adverse event reporting, electronic prescribing and medicines control in the supply chain.

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Arlen Ward, System Insight Engineering
October 12, 2020
Arlen Ward, System Insight Engineering

Computer Modeling and Simulation Helps MedTech Developers Bring Innovation to Reality

By Maria Fontanazza
No Comments

No longer just “the big company advantage,” Arlen Ward discusses how CM&S is an accepted and viable device industry path to market for large and small medical device makers alike.

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Checkbox
September 2, 2020
Checkbox

Cybersecurity, COVID-19 and EU MDR Hot Topics of the 2020 MedTech Summer

By MedTech Intelligence Staff
No Comments

Although the full impact of COVID-19 is uncertain, one sure thing is that industry continues to crave information to help them navigate EU MDR.

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Ames Gross, Pacific Bridge Medical
August 4, 2020
Ames Gross, Pacific Bridge Medical
Ameing for Asia

Asian Governments, Private Sector Response to Pandemic Shows Opportunity, Challenge

By Ames Gross
No Comments

In general, the Asian markets have controlled the COVID-19 virus successfully outside of China, but its effect has still led to new developments and trends.

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Abbott FreeStyle Libre 2
June 15, 2020
Abbott FreeStyle Libre 2

FDA Clears Abbott’s Continuous Glucose Monitoring System for Use in Children

By MedTech Intelligence Staff
No Comments

The FreeStyle Libre 2 now has indications for children ages four and older.

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FDA
May 25, 2020
FDA

In Face of COVID-19, FDA Updates Adverse Event Reporting Guidance Document

By MedTech Intelligence Staff
No Comments

The goal of the guidance is to ensure that manufacturers are prepared to report adverse events during a pandemic.

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Remco Munnik, Iperion
May 15, 2020
Remco Munnik, Iperion
Soapbox

Essential Data Preparations for AI

By Remco Munnik, Steve Gens
No Comments

Smart process automation promises to cut complexity and transform product traceability in the medical device industry. However, its potential relies 100% cent on having good, reliable data on which to draw.

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Medtech, innovation
April 10, 2020
Medtech, innovation
Soapbox

Compliance Date Approaching for FDA Unique Device Identifiers

By Amy Scanlin
No Comments

Timely compliance will ensure that your products will not be considered misbranded.

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Ames Gross, Pacific Bridge Medical
April 8, 2020
Ames Gross, Pacific Bridge Medical
Ameing for Asia

Amid Pandemic, Augmented and Virtual Reality Offer Promise in Asian Markets

By Ames Gross
No Comments

With the Covid-19 pandemic increasingly forcing healthcare testing, diagnosis and treatment online, the promise of augmented and virtual reality is drawing deepening interest in Asia’s medtech market.

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