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MedTech Intelligence

Volume 10 Issue No. 50

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

FDA Encourages Innovation and SafetyFDA Encourages Innovation and Safety as Part of
Medical Device Regulatory Overhaul

By Amy Scanlin, EAS Consulting Group, LLC

The agency’s latest announcements are indicative of its focus on risk reduction while promoting innovation.

Featured Articles
EU MDR Compliance

Maria Fontanazza, Editor-in-ChiefFirst Step in EU MDR Compliance: The Gap Analysis

By Maria Fontanazza, Editor-in-Chief

A gap assessment provides a toolbox for the decision-making process.


Bryan Brosseau, Brosseau Consulting, LLCEU MDR Post-Market Surveillance: Active, Integrated, Risk-Based,
and Planned

By Bryan Brosseau,
Brosseau Consulting, LLC

Post-market requirements outlined in the regulation carry significant process challenges and procedure updates. Start simple and try not to overcomplicate your processes.


Ameing for Asia

Ames Gross, Pacific Bridge MedicalWestern Companion Diagnostic Firms Gain Foothold in the Japanese Market

By Ames Gross, Pacific Bridge Medical

This mode of personalized medicine helps doctors make more informed decisions related to drug therapies.

Brian Ochs, 3M Medical Materials and TechnologiesFive Stages to Bringing a New Medical Device to Life

By Brian Ochs,
3M Medical Materials and Technologies

While the road to bringing a medical device to market is often bumpy, working with an experienced and knowledgeable partner can help navigate the process and potentially avoid some of the bumps.


FDAFDA Commish and CDRH Director Announce Agency Actions to Enhance Patient
Safety Using Data

By MedTech Intelligence Staff

The agency will be improving postmarket surveillance, looking at issues that come up once a device is on the market, and promoting innovation.

Sponsored Content

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More Articles »


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Upcoming Events & Webinars

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

March 2019March 5-6, 2019 - EU MDR the Cost of Compliance: Assessing Infrastructure and Resource Impact
Washington, DC

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

April/May, 2019 - Med Tech Import/Export
Washington, DC

April/May, 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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