UL - ISO 13485:2016 Upgrade Preperation Checklist for Medical Device Manufacturers

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MedTech Intelligence

Volume 9 Issue No. 16

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

Maria Fontanazza, Editor-in-ChiefFDA Squashes Five
Cybersecurity Myths

By Maria Fontanazza, Editor-in-Chief

The agency clarifies some misconceptions about requirements.

Barcoding in the NHSBarcoding in the NHS
and the run-up to UDI

By Peter Rose, Maetrics

UK and European manufacturers should put a UDI implementation plan in place ASAP.


Test your ISO 13485 IQ: Part IITest your ISO 13485 IQ

Part II

By MedTech Intelligence Staff

Part II of the ISO 13485 IQ test digs a little bit deeper into the standard.

MedtronicCardinal Health Picks Up Medtronic’s Patient Monitoring and Recovery
Division for $6.1 Billion

By MedTech Intelligence staff

Medtronic will keep its respiratory and monitoring solutions business, while Cardinal will buy the patient care, DVT, and nutritional insufficiency businesses.

Devine Guidance

Christopher Devine, Ph.D., Devine Guidance International Inform FDA of Design Changes!

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

If device modifications could affect safety and effectiveness, a premarket notification submission is required.

A Missed OpportunityIncorporating Human Factors Engineering into Product Development

By Jon Tilliss and Allison Strochlic,

Companies should not underestimate the importance of investing in user experience design.

Sponsored Content

3 Must Ask Questions Before Choosing an Injection Molder3 Must Ask Questions Before Choosing an Injection Molder

When choosing an injection molder for manufacturing your plastic components or devices, there are some mandatory guidelines that should be reviewed to determine how to choose the right company. These three questions are type of Quality Management System, can they support your Entire Product Life Cycle and Project Support once you have made your choice. This will help to minimize risk for the scope of your project and ensure you have selected the right injection molder.

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More Articles »

Sponsored Resources

SGSISO 13485 Live Virtual Training — Friday May 12th

Expand your knowledge of ISO 13485:2016 and sharpen the interpretive skills necessary to navigate the new requirements of ISO 13485:2016.

Upon successful completion, you will have gained an overview of the new requirements / changes from the ISO 13485:2003 / EN ISO 13485:2012 version to the 2016 version of ISO 1348, and increased ability to interpret the new requirements of ISO 13485:2016

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Upcoming Events & Webinars

May, 2017May 2017 - HHE, Benefit-Risk, and Recalls

Washington, DC

June 5-6, 2017 - China: The MedTech Market

Washington, DC

July 2017July 26-27, 2017 - The New EU Medical Device & IVD Regulations

Washington, DC

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

Washington, DC

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

Washington, DC

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