MedTech Intelligence Volume 10 Issue 42

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	Volume 10 Issue No. 42

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

MEDdesign

Christopher McCann, snap 40 Blood, 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.

Featured Articles

Lars Thording, Innovative Health Planned 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 MDR Take the EU MDR Compliance Cost Questionnaire

By MedTech Intelligence Staff

Does your company understand the magnitude of the compliance effort?

Bryan Brosseau, Brosseau Consulting, LLC Corrections, 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.

Featured Quote

Modern MES [manufacturing execution systems] not only offers a way of reducing audits through improved quality, they also provide a pathway to efficiently dealing with audits when they arise.

— Chris Parsons, Critical Manufacturing

Recall Endologix 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.

Soapbox

Tim Jennings, Custom Case Group A 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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Neurotechnology: Advancing Beyond Expectations

TransPerfect Medical Device Solutions - Content Solutions for MDR/IVDR Compliance

Emergo by UL - Simple and Easy Device Registration Management - RAMS TRACK

Save the Dates! - EU MDR Implementation Strategies Workshop - November 27-28, 2018 - Washington DC

Resource Centers

Resource Centers are single topic focused micro-sites within MedTechIntelligence.com that are portals of information on medical device components and quality systems offering news, articles, white papers, case histories and videos.

Medical Device Audits, Certification & Verification
Quality & Regulatory Market Access Solutions
sponsored by UL
Medical Device Component
sponsored by 3M
Medical Recall

Sponsored Resources

Master Control Designing 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

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

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

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

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

January 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