Medical Device Design Control

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Automation of the Design Control process can help product development teams navigate mandatory FDA regulations for medical device design controls.  By making this process easier and more efficient, innovative medical devices can get to market quicker thereby having a greater impact of people’s lives.  Tietronix Software has developed a Medical Device Accelerator (MDA), a web based system that includes design … Read More

FDA ISO 13485 Voluntary Audit Report Submission

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FDA CDRH is kicking off their ISO 13485:2003 Voluntary Audit Report Submission Pilot Program June 5, 2012.  FDA wants to explore how they can leverage off of some of the ISO 13485 audits being conducted by ISO conformity assessment bodies. The premise of the 13485 Voluntary Audit Report Submission Program was based on an amendment to the law, which is … Read More