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FDA Software Validation

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. Read this white paper to see how Cloud QMS simplifies software validation.

Helping You Innovate to Change the World

Thermo Fisher
medtronic
Bio Rad

About Arena

Arena Solutions helps innovative electronic high tech and medical device companies create products that change the world. Arena unifies product lifecycle (PLM) and quality management (QMS) processes, allowing every participant throughout the product realization process from design to manufacturing to work together. With Arena, teams accelerate product development and delivery to increase profits. For more information, visit ArenaSolutions.com.

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