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

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MedTech Intelligence

Volume 9 Issue No. 50

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

Maria Fontanazza, Editor-in-ChiefThemes of Risk and Uncertainty Continue for 2018

By Maria Fontanazza, Editor-in-Chief

PwC’s Health Research Institute releases its annual Top Health Issues report.

 
 

Edwards Lifesciences CorporationEdwards Lifesciences Eyes
$4 Billion Mark for 2018, Acquires Harpoon Medical

By MedTech Intelligence Staff

This year the company exceeded its expectations, too.

Ameing for Asia

Ames Gross, Pacific Bridge MedicalFollowing Trump to Asia

By Ames Gross, Pacific Bridge Medical

The President’s actions (or distractions) may be detrimental to Western medical device companies.

Devine Guidance

Christopher Devine, Ph.D., Devine Guidance International Sixteen Form 483 Observations. Ouch!

By Christopher Devine, Ph.D.,
Devine Guidance International

There really is not much rocket science involved when attempting to determine the odds of a device establishment being awarded a prized agency warning letter when the establishment is on the receiving end of sixteen Form 483 observations during an inspection.

CybersecuritySafeguarding Medical Devices Against Cyber-Attacks

By Anura Fernando, UL

By adhering to FDA recommendations and leveraging the expertise of proven cyber testing methods, manufacturers can tackle known cybersecurity issues today while also attempting to anticipate concerns that may lie ahead.

 
Sponsored Content

AccumoldWhat is Micro Molding?

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More Articles »

Sponsored Resources
 
 

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

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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 - HHE & Recalls
Washington, DC

Jun 2018June 14-15, 2018 - MedTech Regulatory Summit
U.S. Pharmacopeia - Rockville, MD

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

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