MedTech Intelligence Volume 10 Issue 40

Get Your FREE Subscription Here! About Us
	Volume 10 Issue No. 40

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

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 Articles

For 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.

Featured Quote

We continue to work to encourage device innovation for medical conditions that impact young populations. Our Pediatric Device Consortia Grant Program is one of a number of initiatives underway to foster the development and approval of safe and effective pediatric-specific medical devices.

— Scott Gottlieb, M.D., FDA

MEDdesign

Abbas Dhilawala, Galen Data The 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.

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

3M - Creating a Medical Device? Do you have the right adhesive?

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

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

MPO Summit 2018 - October 11-12, 2018 - Colorado

Sponsored Resources

Pacifc Bridge Medical Find Reliable Sourcing & Manufacturing Partners You Can Trust in Asia

Asia has become the chief manufacturing center for medical devices and components, but common poor supply chain practices in the Asian markets can have a serious negative impact on your business. PBM’s on-the-ground experts in Asia will assist you in finding experienced manufacturers, conducting quality audits, ensuring compliance with standards, managing the supply chain, and more.

Learn about how we can help you build long-term, reliable sourcing and manufacturing partnerships.

Neurotechnology: 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

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

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