Medical device manufacturers are racing to capitalize on innovative new business models enabled through outcome-based reimbursement. Meanwhile, increasing regulatory requirements like EU MDR and initiatives like FDA's Case for Quality program put a growing emphasis on product quality and post-market surveillance.

At LiveWorx 2018, Kalypso will bring to life a fully integrated smart, connected medical device program.

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By harmonizing PLM, IoT and advanced analytics, medical device manufacturers can dramatically decrease their quality and compliance costs, patients benefit from higher quality devices at a lower cost point, and the industry benefits from more accurate outcome-based healthcare results.

Using the Fresenius Hemodialysis Delivery System, Kalypso will demonstrate a world-class medical device quality and compliance program. By closing the loop between clinical operations, product development, regulatory and post-market surveillance, this program enables industry-leading quality over the entire product lifecycle.

Using advanced analytics, Product Lifecycle Intelligence (PLI) develops actionable insights from data developed throughout the lifecycle. PLI helps quickly and accurately diagnose root causes, predict future performance and implement preventive action that will reduce cost of quality, enhance compliance, offer assurance into product performance, and close the loop between scientists and the business.

Concerned about security? We partnered with Device Authority to show how their KeyScaler security platform provides a strong root of trust, securing the medical device’s identity and offering an automated approach for registering and authenticating devices for ThingWorx. KeyScaler also offers policy-based encryption for data security and solves compliance requirements.

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