FMEA Software for Medical Devices
FMEA-Med™ 7 is the leading Failure Mode and Effects Analysis software solution for medical device and pharmaceutical manufacturers. It helps improve quality, productivity, and safety while providing a means for reviewing product and process designs and ensuring compliance with strict regulations and industry standards.

FMEA-Med has become the standard tool of choice for numerous corporations world-wide including Fortune 500 companies.
Increase Efficiency
FMEA-Med is an efficient all-in-one solution that helps better analyze product designs and manufacturing processes, dramatically shorten study time, achieve more thorough studies, and prevent failures from happening in the first place.

FMEA-Med's comprehensive libraries and templates provide a solid knowledge base for speedy and precise studies. In addition, enhanced security features ensure control over access to information.

Using FMEA-Med can reduce time spent on your process or design FMEA analysis by up to 65% over using a generic spreadsheet.
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Reduce Costs
It has been estimated that companies will spend as much as 40% of their annual revenue correcting existing quality problems.
The FDA estimates that 45 to 50% of all device recalls are attributed to poor product design (including problems with software). A recall for a minor part can quickly add in cost. For example if you have to recall 600,000 units to replace a $0.50 part, your recall would cost $300,000 for parts alone, you still have to factor in time and wages used by your staff to carry out the repair, as well as shipping and handling costs. Less tangible costs include possible legal actions and loss of future business. A defective $0.50 part can have serious legal and financial impacts on your company.
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