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MedTech Intelligence

Volume 10 Issue No. 23

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

DA Launches Innovation ChallengeFDA Launches Innovation Challenge to Fight Opioid Misuse and Abuse

By MedTech Intelligence Staff

CDRH is urging the development of medical technologies and diagnostic tests that address pain, addiction and diversion.

Devine Guidance

Christopher Devine, Ph.D., Devine Guidance International Seriously, No Audits Performed Since 2015?

By Dr. Christopher Joseph Devine,
Devine Guidance International

Smaller establishments that are just getting started in the medtech industry may not have the resources to perform effective audits; however, not having the resources to perform audits is not a viable excuse.

Trending: Innovation in Active Implant TechnologyTrending: Innovation in Active Implant Technology

By Klaus Jopp, Freelance writer

The market is being driven by smaller components, wireless technology and new control systems.

 
 

FDA Alerts on Liquid-Filled Intragastric BalloonsFive More Deaths, FDA Alerts on Liquid-Filled Intragastric Balloons

By MedTech Intelligence Staff

This is the second alert the agency has issued in less than one year.

Soapbox

Jon Speer, Greenlight GuruUnderstanding FDA’s Guidance on Medical Device Reporting

By Jon Speer, Greenlight Guru

How in touch are you with current MDR guidelines?

 

More Articles »

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Save the Dates! - EU MDR - 13486:2016 - MDSAP: Implementation Workshop - November 27-28, 2018 - Washington DC

Upcoming Events & Webinars

Sept. 2018September 13-14, 2018 - MedTech Product Claims - What Can You Say?
Washington, DC

Sept. 2018September 17-18, 2018 - Medical Device Process Validation Virtual Conference
Washington, DC

Oct. 2018October 22-23, 2018 - MedTech Mergers & Acquisitions Conference
Washington, DC

Oct. 2018October 24, 2018 - Medical Technology: Import/Export Workshop
Washington, DC

Nov. 2018November 27-28, 2018 - EU MDR – 13485:2016 – MDSAP: Implementation Workshop
Washington, DC

Nov. 2018November 29-30, 2018 - Advanced CAPA and Root Cause Analysis Workshop for Medical Device Companies
Washington, DC

Q1 2019Q1 2019 - Digital Health Technologies Conference
Silicon Valley, CA

Q1 2019Q1 2019 - Medical Cybersecurity - Remediation of Legacy Medical Devices
Silicon Valley, CA

Q1 2019Q1 2019 - MedTech Innovation Mergers & Acquisitions Workshop
Silicon Valley, CA

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