Conquer Product and Regulatory Complexity through Smart Technology in Medical Devices
One challenge medical device companies are faced with is how to bring together the organizational functions and processes that make up product design in a way that efficiently delivers final products that are greater than the sum of their parts (as defined by effectiveness, safety, compliance, and quality). The only way to do this is to conquer product and regulatory complexity through smart technology in medical devices.
Utilize design control guidance for medical device manufacturers to build design models
Program complexity is a common symptom for many root causes that lead to challenges with medical device design. A baseline to address this is a running concrete history of design in context; this enables design controls to be effectively re-used to reduce complexity and meet regulatory demands. Utilizing design control guidance for medical device manufacturers to build design models offers organizations agility and confidence in a product’s quality, safety, and regulatory data.
The tools’ ability to exchange data directly eliminates the administrative burden and the associated opportunity for mistakes and miscommunications that could slow the process further down the line. This means integrating your medical CAD software with tools that are not only world-class, but capable of integration and intelligent communication across the chain of command. This includes simulation software to create an accurate real-world simulation of both products and the patients using them that will provide a critical opportunity to monitor and protect the patients who rely on medical devices.
With integrated tools, processes, and teams working towards a holistic common goal powered by a comprehensive digital twin of products and processes, companies enable greater design integrity, comprehensive digital evidence strategy, and a ledger of institutional knowledge.
Read more in this brief on how to excel in medical device design and development through design excellence.
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