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Report Arena Solutions FDA Software Validation: How Cloud QMS Reduces Costs and Resource Drains

FDA Software Validation: How Cloud QMS Reduces Costs and Resource Drains

Medical device companies must overcome many hurdles to get safe, high-quality products to market.

While their primary objective—creating safe, innovative, and valuable health solutions—is challenging enough, medical device companies must also navigate a myriad of regulatory compliance issues before products can be sold to doctors, hospitals, and patients. Establishing and maintaining an effective quality management system (QMS) to satisfy both the FDA and ISO is critical. And, when the system is software-based, then the manufacturer must also demonstrate and provide evidence, or validate that it meets the requirements to consistently deliver safe, high-quality devices to market.

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According to a study by LNS Research, software validation is one of the top challenges in speeding products from R&D to market for life science companies.

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