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10 CAPA Tips for the Medical Device Industry

January 27th, 2016 by

Male Scientist Using Medical ToolsThe CAPA process from the side of regulatory compliance of both U.S. FDA requirements (21 CFR 820.100) and EU regulatory requirements ([...] Read More

Outsourcing and the Device Manufacturer’s QMS Accountability

August 6th, 2015 by

Global Medical Technology ComplianceIn 2003, the International Organization for Standardization (ISO) issued ISO 13485, officially known as EN ISO 13485:2003. This voluntary international standard provides a framework to assist medical [...] Read More

How Does ISO 13485 Affect Your Company’s Ability to Do Business?

February 13th, 2014 by

ISO 13485 ComplianceAlthough medical device manufacturers have to adhere to a number of pertinent regulations to access foreign markets, there are some that stand out amongst the others. ISO 13485 is one such standard, and many firms strive to attain compliance with it.

Why ISO 13485?

For many medical [...] Read More