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Home » regulations

Articles Tagged with ''regulations''

How to Work With Medical Device Design Firms

How to Work With Medical Device Design Firms

Third-parties can help new products get to market faster.
Austin Weber
Austin Weber
February 2, 2017

Designing a new medical device is a bit more complicated than designing a toaster or an automotive cooling system. Besides the issues common to any product—feasibility, usability, and design for manufacture and assembly—there are also issues of biocompatibility, sterilization and FDA regulations to deal with.


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NAM Study Puts $81 Billion Price Tag on New Labor Rules

October 3, 2016

WASHINGTON—Labor regulations implemented during the Obama administration could cost an estimated $81 billion over the next 10 years and require more than 400 million hours in paperwork, according to a new study from the National Association of Manufacturers’ Center for Manufacturing Research.


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Ensuring Traceability in Electronics Assembly

Rob Prosser
August 1, 2015

Data from a traceability system can be used for process improvement, defect resolution and regulatory compliance.


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US Manufacturers Have Dramatically Cut Pollution

John Sprovieri
June 4, 2015

Close your eyes for a moment and think about the word manufacturing. What image came to mind?


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How to Respond to FDA Form 483

Austin Weber
Austin Weber
January 5, 2015

Manufacturers must react promptly or they risk getting a Warning Letter.


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FDA Warns Texas Medical Device Manufacturer

June 5, 2013

STAFFORD, TX—The FDA issued a warning to CooperSurgical after inspectors noted violations at the company’s assembly plant here.


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Smog Smothers Beijing

January 16, 2013

BEIJING—Air pollution levels were literally off the charts here over the weekend, reportedly reducing visibility to about 100 yards in some areas and prompting some flight cancellations. Residents in several Chinese cities have been advised to stay indoors, and at least four deaths have been blamed on the smog.


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Regulation Strangulation

John Sprovieri
November 1, 2012

The burden of federal regulations was a hot topic on the campaign trail this year. 


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Report: Federal Regulations Will Reduce GDP by $630 Billion

October 9, 2012

WASHINGTON—A new report finds that U.S. manufacturers are subject to 2,183 different federal regulations promulgated since 1981, and those regulations will decrease the nation’s GDP by as much as $630 billion this year.


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FDA Warns Medical Device Manufacturer

October 9, 2012

WASHINGTON—The U.S. Food and Drug Administration has warned Zimmer Holdings Inc. about its practices for manufacturing and testing hip implants at an assembly plant in Puerto Rico.


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