Monthly Archives: June 2012

ITAR at Columbia Tech

Posted on June 25, 2012 by admin

Prepared by Rich Schulman, Vice President of Quality and ITAR Technology Control Officer and Gerry St. Jean, Manager Audits and Training. Columbia Tech has, for the fourth year in a row, successfully obtained ITAR re-registration from the Department of State.  … Continue reading →

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Software Validation for Medical Device Companies

Posted on June 19, 2012 by admin

It’s important to recognize that there are FDA Quality System Regulation and ISO 13485 requirements that govern the use of electronic systems [software such as ERP, MES, WMS, PDM, etc] in all forms of medical device manufacturing companies including medical … Continue reading →

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Could the Medical Device Excise Tax Affect Your Company?

Posted on June 8, 2012 by admin

As its effective start date nears, there is rapid growing debate around the medical device excise tax; a 2.3% (of revenue) excise tax on medical products not sold over the counter directly to consumers.  Government excise taxes have been in … Continue reading →

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BiOM Ankle Recognized in Medical Design Excellence Awards

Posted on June 5, 2012 by admin

The winning products in this year’s Medical Design Excellence Awards (MDEA) competition, presented by UBM Canon, were announced in Philadelphia on May 23. The finalists were honored for their innovations to the MedTech industry. Each product was reviewed by a panel … Continue reading →

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