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MedTech Intelligence

Volume 10 Issue No. 40

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

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.

Best Strategies to Succeed in Asia's Medtech Markets Webinar - October 25, 2018 - 12:30pm EST

Featured Articles

ECRI Health Tech Hazards ListFor Second Year in a Row, Cybersecurity Issue Tops ECRI Health Tech Hazards List

By MedTech Intelligence Staff

Hackers and their ability to access systems remotely and disrupt healthcare organizations are a key concern.



Abbas Dhilawala, Galen DataThe Connected Economy:
Opportunities and Barriers in Healthcare

By Abbas Dhilawala, Galen Data

A look at the pros and cons of connected medical devices.

Devine Guidance

Christopher Devine, Ph.D., Devine Guidance International Device History Records
and Rework

By Dr. Christopher Joseph Devine,
Devine Guidance International

The FDA wants to know that rework activities are not impacting product safety and efficacy issues or influencing long-term product reliability.


More Articles »


Resource Centers

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

MedTech M&A: Regulatory & Quality Due Diligence

Sponsored Resources

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BattelleNeurotechnology: Advancing Beyond Expectations

Webinar: October 30th @ Noon EDT - Register Today!

Join Battelle to learn more about the three aims of our neurotechnology research: assist, restore and advance. We’re assisting the body to go beyond physical limitations where biology is broken. We’re restoring the body by optimizing recovery through targeted neuroplasticity and bioelectronic medicine. And finally, we’re advancing the healthy body to perform beyond current physical and cognitive abilities.

Upcoming Events & Webinars

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

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

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