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MedTech Intelligence

Volume 10 Issue No. 03

Business Analysis Combination Products Market Access Operations Product Development Quality/Regulatory
 
Featured Articles

FDAFDA and DoD Launch Program
to Prioritize Device Development for Military

By MedTech Intelligence Staff

The program aims to ensure that life-saving devices are available in battlefield settings.

Wearable BiosensorsDo Wearable Biosensors Improve Patient Outcomes?

By MedTech Intelligence Staff

The jury is still out, according to an analysis conducted by Cedars-Sinai.

WarningBecton Dickinson Receives FDA Warning Letter for Significant Violations

By MedTech Intelligence Staff

The agency found several violations during an inspection related to its investigation of inaccurate blood lead test results.

 
 

RecallEdwards Recalls Delivery System Used for SAPIEN Heart Valve

By MedTech Intelligence Staff

The Class I recall is a result of a mold overflow defect that could obstruct blood flow.

 

Part I:
An Overview of Medical Device Software
& Products Liability

Certain chronic conditions, such as spinal disorders, could benefit from the use of medical devices versus long-term opioid treatment.

Part II:
The Homefront of Medical Device Software
& Products Liability

An examination of the use of software in medical devices in non-clinical settings, particularly the home environment.

 

More Articles »

Sponsored Resources
 
 

Evaluation of Wear Time for Various Tapes on Human Volunteers: 21-day Study

Sponsored by
Sponsored by: 3M

Evaluation of Wear Time for Various Tapes on Human Volunteers: 21-day Study

Download your copy of Evaluation of Wear Time for Various Tapes on Human Volunteers: 21-day Study to understand challenges when adhering to human skin.

As a device manufacturer, your key consideration when selecting a tape is ensuring proper adhesion to the patient’s body. Medical adhesives can be used in a variety of applications, such as securing wearable sensors, health monitors or other medical devices. Depending on the user population, some adhesives – typically in tape form - need to be gentle for fragile skin, or able to adhere even in moist conditions. Whether it’s affixed for several hours, a day or even a week, your device needs to stay attached to do its job. While adhesion is critical, there are other factors that need to be considered.

Download Your 21-Day Wear Time Study

 

Upcoming Events & Webinars

Jan 2018January 23-24, 2018 - Premarket Submissions: 510(k) and de Novo Pathways to Market
A Virtual Conference

Feb 2018February 6-7, 2018 - Premarket Submissions: PMA Submissions Workshop
A Virtual Conference

Feb 2018February 13-14, 2018 - Medical Device Statistics for Non-Statisticians
A Virtual Conference

Feb 2018February 20-21, 2018 - Premarket Submissions: FDA Submissions Strategy
A Virtual Conference

Mar 2018March 6-7, 2018 - New Concepts in Risk Management
Washington, DC

Mar 2018March 26-27, 2018 - Cybersecurity Vulnerability Management
Washington, DC

Mar 2018March 26-27, 2018 - Cybersecurity Patch Management
Washington, DC

Q2 2018Second Quarter, 2018 - Cybersecurity: Remediation of Legacy Devices
Washington, DC

Apr 2018April 2018 - China – the MedTech Market
Boston, MA

May 2018May 14-15, 2018 - Medical Device Recalls: Current Topics & New Initiatives
Washington, DC

Jun 2018June 6-8, 2018 - MedTech Regulatory Summit
The United States Pharmacopeial Convention - Rockville, MD

Jun 2018June 26-27, 2018 - Developing Appropriate Medical Technology
Carolinas HealthCare System - Charlotte, NC

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