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MedTech Intelligence

Volume 9 Issue No. 24

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

Devine Guidance

Christopher Devine, Ph.D., Devine Guidance International Recall, That Nasty
6-Letter Word!

By Christopher Devine, Ph.D.,
Devine Guidance International

This offending company has “significant” violations regarding reporting corrections and removals to FDA.

Microfluidics Brings the Modern Lab to Point of CareMicrofluidics Brings the Modern Lab to Point of Care

By Klaus Jopp, Technical writer

Research around the global is focusing on a faster, more precise approach in diagnostics.


510(k)s for Reusable Devices Must Include Validated Data for Cleaning in IFUs510(k)s for Reusable Devices Must Include Validated Data for Cleaning in IFUs

By MedTech Intelligence Staff

Reusable devices have become more difficult to clean, disinfect and sterilize. FDA is now requiring clear instructions for effective reprocessing.

Selecting a Drug Delivery Device that Meets User NeedsSelecting a Drug Delivery Device that Meets User Needs

By Allison Strochlic and Erin Davis, UL-Wiklund

In haste to get to market, some pharmaceutical companies select a device without fully considering whether intended end-users can use the device safely and effectively.

FDA Approves Expanded Use of Sapien 3 for Valve-in-Valve TreatmentEdwards Lifesciences Wins FDA Approval for Expanded Use of Valve-in-Valve Treatment

By MedTech Intelligence Staff

The expanded indication is for patients who are at high or greater risk of complications from repeat surgery.

Sponsored Content

5 Things Everyone Should Know
about Micro-Molding

With the pressure on design engineers to deliver smaller, lighter and more cost-effective components many are turning to micro injection molding for support. Challenges often arise when designing for micro molding that can present unforeseen road blocks. Questions like – What is micro molding? How is it different from standard molding? Or, what do I need to know to be successful at molding a micro plastic part? - are commonly asked by engineers. Download 5 Things Everyone Should Know about Micro-Molding to learn the answers to these and other questions.


More Articles »

China: The MedTech Market - November 2-3, 2017 - Washington, DC
Sponsored Resources

Pacific Bridge MedicalQuality Compliance in the Asian Medical Markets

Ensuring the quality of your medical products is an essential step when sourcing or manufacturing medical devices or device components in Asia. Read more about the importance of stringent quality management and learn how Pacific Bridge Medical's Asia team can assist you in Asia with quality control (QC), quality assurance (QA), quality management systems (QMS), and more.

Upcoming Events & Webinars

July 2017July 18, 19, 20, 2017 - Premarket Submissions

Washington, DC

August, 2017August 29-30, 2017 - The New EU Medical Device & IVD Regulations

A Virtual Conference

September 2017Q3 2017 - Medical Device Statistics for Non-Statisticians

Washington, DC

Oct. 2017October 23, 24, 25, 2017 - Premarket Submissions

Menlo Park, CA

November 2017November 2-3, 2017 - China: The MedTech Market

Washington, DC

Dec. 2017December 4, 5, 6, 2017 - Premarket Submissions

Schaumburg, IL

Dec. 2017Q4 2017 - Combination Products: A Conference for Drug, Device, Diagnostics, & Biologics Manufacturers

Washington, DC

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