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Medical Product Documentation for FDA Approval and Oncology Professionals
Sicel Technologies®, a leader in the development of systems and technologies specific to cancer therapy, was preparing to release DVS®, its Dose Verification System. DVS is a product consisting of hardware and software and is designed for use in radiation therapy to verify treatment planning and radiation dose. In support of this release, Sicel needed FDA-approved documentation to guide both physicians and other radiation oncology professionals on the appropriate use of the product.
While Sicel had developed much of the technical content for the documentation, they needed Contiem’s help with organizing, editing, and rewriting the content for the target audience and adding new content. Contiem also needed to produce the documentation with a professional visual design and to provide a developmental edit ensuring the content was well-positioned for translation into multiple languages.
Contiem developed a two-pronged approach to meet Sicel’s challenge quickly and efficiently. A writer and an editor focused on content improvement and development, while a desktop publisher developed templates for each of the deliverables: a black-and-white Product Insert and a full-color Operator Manual.
The Product Insert primarily focused on the information needs of physicians, who would be interested in clinical data and would be using the implantable DVS dosimeter.
The Operator Manual was geared toward users of the DVS Reader hardware and the software used to collect data from the implanted dosimeters.
Contiem organized the project to complete work on the Operator Manual while awaiting final FDA clearance on the Product Insert. The project was completed on schedule, which allowed Sicel to achieve its product launch date. Readers find the content in both deliverables to be accurate, complete, and easy to find, and Sicel is confident that the clear, consistent language will facilitate future translation.
No matter the challenge, Contiem works with its clients to ensure that the right solution is developed to meet overall goals and objectives. For Sicel, documentation was critical to the product launch and was required to be clear, concise, and suitable for future translation. Whether it is meeting a deadline for a product launch or updating documentation as part of a new release, Contiem considers all elements necessary to ensure that product documentation meets the requirements of the target audience, is ready for translation, and is designed to minimize overall costs.