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MedTech Intelligence

Volume 10 Issue No. 42

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


Christopher McCann, snap 40Blood, Sweat and Big Ideas:
Why Is It So Hard to Innovate in Health Tech?

By Christopher McCann, snap 40

A great idea is not the same as great execution.

MedTech M&A: Regulatory & Quality Due Diligence

Featured Articles

Lars Thording, Innovative HealthPlanned Obsolescence and Single-Use Reprocessing in Healthcare

By Lars Thording, Innovative Health

As medical device costs continue to be a growing area of hospital expenditures, many hospitals control the savings through device reprocessing programs. The shift toward planned obsolescence is especially troubling given the financial challenges many hospitals face.


EU MDRTake the EU MDR Compliance Cost Questionnaire

By MedTech Intelligence Staff

Does your company understand the magnitude of the compliance effort?

Bryan Brosseau, Brosseau Consulting, LLCCorrections, Corrective Actions, and Preventive Actions:
Effectively Handling Nonconformances in Compliance with the EU MDR

By Bryan Brosseau, Brosseau Consulting, LLC

An explanation of these principles and the actions that must be addressed in compliance with 21 CFR 820, ISO 13485 and the EU MDR.


RecallEndologix Recalls More Than 61,000 AAA Systems Due to Endoleak Risk

By MedTech Intelligence Staff

There have been reports of Type llla and lllb endoleaks related to the company’s AFX Endovascular AAA Systems.



Tim Jennings, Custom Case GroupA New Frontier for AR/VR

By Tim Jennings, Custom Case Group

While most laypeople associate augmented reality (AR) and virtual reality (VR) with gaming and entertainment, these revolutionary technologies are beginning to gain global recognition for helping medical professionals treat, prevent and raise awareness about serious diseases and conditions.

Sponsored Content

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More Articles »


Medical Device Process Validation: A Virtual Conference - January 29-30, 2019

Sponsored Resources

Master ControlDesigning for quality is key to 510(k) success

In the medical device industry, investor confidence is high, but the competition is on the rise. The margin between getting a product to market ahead of your competition and falling short is very thin. Achieve regulatory compliance with digital QMS technology and get products to market sooner.

Upcoming Events & Webinars

Oct. 2018October 22-23, 2018 - Med Tech M&A: Regulatory & Quality Due Diligence
Washington, DC

Oct. 2018October 30, 2018, 12:00pm - Neurotechnology: Advancing Beyond Expectations
Webinar sponsored by Battelle

Nov. 2018November 27-28, 2018 - EU MDR Implementation Strategies Workshop
Washington, DC

JanuaryJanuary 23-24, 2019 - Advanced CAPA and Root Cause Analysis Workshop for Medical Device Companies
Washington, DC

JanuaryJanuary 29-30, 2019 - Medical Device Process Validation
A Virtual Conference

February 5-6, 2019 - EU MDR Remediation Strategy
Washington, DC

February 6-7, 2019 - EU MDR Clinical & Postmarket Surveillance Strategies
Washington, DC

March 5-6, 2019 - Med Tech Import/Export
Washington, DC

March 7-8, 2019 - EU MDR Supply Chain & Economic Operators
Washington, DC

April 11-12, 2019 - EU IVDR Implementation
Washington, DC

May 7-8, 2019 - Medical Device Cybersecurity: Legacy Device Remediation, Compensating Controls, & End-of-Life
Cambridge, MA

May 21-22, 2019 - Medical Device Recalls: Current Topics & New Initiatives
Washington, DC

May 23-24, 2019 - EU MDR Labeling, IFU, UDI, & Eudamed
Washington, DC

June, 2019 - Global Regulatory Strategy
Washington, DC

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