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Regulatory Solutions: Medical Devices Making sure that quality information is ready when a product is launched has always presented a challenge. The challenge is even greater for medical device manufactures because the information is a critical step in the filing requirements. And the information needed for filing may not map directly to the needs of the various internal and external audiences, such as sales, support, clinical staff, and other end users. At Lasselle-Ramsay we begin with the information requirements of all audiences, including regulatory agencies. We build an information model that addresses the needs of each audience and maps directly to your product development life cycle. The result is that users get the information they need in the form they need it. Lasselle-Ramsay's approach fundamentally transforms the product information process by unifying the islands of information that typically exist in various areas of your organization, such as sales, support, and user assistance. We use appropriate technology to ensure that the right information gets to the right people at the right time. And we apply the latest methodologies to tailor information to the way people work, which results pays off in increased process efficiencies, time and cost savings, and improved product utilization. and success. Lasselle-Ramsay can work with you to: Create a document and learning stategy that address the content, the content development process, and the technology use to create, store, and deliver the content and learning Build an information model mapped to your product life cycle and the needs of your audiences Provide a complete information and learning solution from design and development to deployment and maintenance including localization Lower information and development costs and shorten time to market through content design and single sourcing Provide innovative approaches to delivering information for clinical, laboratory, and consumers who may not have access to paper documentation or computer workstations

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