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Combination Products

Featured Articles

October 12, 2020
Arlen Ward, System Insight Engineering

Computer Modeling and Simulation Helps MedTech Developers Bring Innovation to Reality

By Maria Fontanazza

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.

September 2, 2020
Checkbox

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

By MedTech Intelligence Staff

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.

June 15, 2020
Abbott FreeStyle Libre 2

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

By MedTech Intelligence Staff

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

May 25, 2020
FDA

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

By MedTech Intelligence Staff

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

March 17, 2020
N95 respiratory mask

Amidst COVID-19 Pandemic, Scams Involving Personal Protective Equipment Emerge

By MedTech Intelligence Staff

As the saying goes, if it looks too good to be true, it probably is.

February 26, 2020
Coronavirus, COVID-19

U.S. Companies Donate Nearly $27 Million in Medical Products to Aid in COVID-19 Outbreak in China

By MedTech Intelligence Staff

AdvaMed has reported that its member companies have provided $26.8 million in medical supplies, along with $4.1 million in cash donations.

February 18, 2020
FDA

FDA Operation Prevented Illegal Shipments of Products from Entering U.S. Market

By MedTech Intelligence Staff

The enforcement operation kept nearly 500 shipments of illegal drugs and combination devices from the hands of consumers.

February 3, 2020
gavel

J&J Must Pay $344 Million for Marketing of Pelvic Mesh in California Case

By MedTech Intelligence Staff

The state’s attorney general said J&J put its profits “ahead of the health of millions of women”.

View More Combination Products Articles »

Columns

November 11, 2020
MEDdesign

Designing the Worst-Case Test to Get Best Case Results

By Dan Fowler
Dan Fowler, WuXi AppTec

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

November 4, 2020
Soapbox

How the COVID-19 Response Is Revealing Potential of IDMP

By Lise Stevens
Lise Stevens, Iperion

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.

August 4, 2020
Ameing for Asia

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

By Ames Gross
Ames Gross, Pacific Bridge Medical

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.

May 15, 2020
Soapbox

Essential Data Preparations for AI

By Remco Munnik, Steve Gens
Remco Munnik, Iperion

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.

April 10, 2020
Soapbox

Compliance Date Approaching for FDA Unique Device Identifiers

By Amy Scanlin
Medtech, innovation

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

April 8, 2020
Ameing for Asia

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

By Ames Gross
Ames Gross, Pacific Bridge Medical

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.

March 25, 2020
Soapbox

We Need Better Data to Make Better Decisions

By Mark Wasmuth
Mark Wasmuth, GMDN Agency

Sources of reliable data to continuously support claims of compliance by manufacturers will be in high demand in the future.

March 11, 2020
Soapbox

How to Get More Mileage Out of Your Electronic IFU

By Charlie Kim
Charlie Kim, Soom

Taking a bare-minimum approach to meeting the eIFU requirements of EU MDR could mean missing an opportunity to improve transparency in healthcare. Here’s how to use eIFU to provide stakeholders with greater confidence and clarity in medical devices.

Upcoming Events & Webinars

May 24, 2022 – 11:00 am – 12:00 pm
Literature Reviews Strategies for Post-Market Surveillance – A Best Practices Webinar


On Demand Events & Webinars

May 12, 2022 – 12:00 pm – 2:30 pm
Telemedicine and Healthcare Outside of the Hospital (Connected Care: Digital Health, Wearables & Connectivity)
March 30, 2022 – 12:00 pm – 1:00 pm
Checkmate: Post-Market Intelligence – A New Global Cost-Effective Strategy
March 16, 2022 – 12:00 pm – 2:30 pm
The Future is Now: Learning from Diabetes (Connected Care: Digital Health, Wearables & Connectivity Series)
January 20, 2022 – 1:00 pm – 2:00 pm
The Silver Lining in Labeling System Validation: Four Tangible Business Benefits
December 15, 2021 – 12:00 pm – 1:00 pm
Connectivity and Beyond – Transforming Medical Devices into Personalized Connected Care Solutions
November 30, 2021 – 11:00 am – 12:00 pm
EU MDR Lessons Learned
November 24, 2021 – 11:00 am – 12:00 pm
From Manual to Automated Literature Reviews for CER & PER Submissions: A Faster Path to Compliance
October 27, 2021 – 1:00 pm – 2:00 pm
Watch Out for Wearables: Medical Devices Regulatory Requirements & Concerns
August 4, 2021 – 12:00 pm – 1:00 pm
Modernizing Your MedTech Selling Process
June 23, 2021 – 12:00 pm – 1:00 pm
Achieving Operational Excellence through Smart Manufacturing in Medical Devices
June 22, 2021 – 12:00 pm – 1:00 pm
Are You Reg. Ready? Getting Your Medical Affairs Team Primed to Manage New Regulatory Requirements
July 28, 2020
Defend Against MedTech Cyber Breach: A Fireside Chat with Critical Healthcare Stakeholders

Combination Products





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