Our collaboration started in 2015 with a request from Maquet to author an IfU (Instruction for Use) for a heart-lung machine where the documentation would accompany the development process. We relied on our extensive experience in authoring during the product development phase for English documentation for laboratory and medical devices as part of international teams, as well as our expertise as a Quanos “Certified Service Provider” to meet Maquet’s requirements.
Text editing with SCHEMA ST4
An on-site prototype was used by Maquet so that our experienced clinical practitioners could familiarise themselves with the product. Coordination meetings and independent training were used to comprehend the topology in Schema ST4. A demo version made it possible to author the software sections during the development phase. Scriptor was included in regular meetings to keep strongly linked to the product and project development. Safety-relevant information was sourced, corrected and verified from many departments. The review of the IfU’s procedures and content took place on-site at the device together with Maquet’s clinical practitioners.
Schema ST4 – Maquet-Server
Deep Exploration
Cinema 4D
Adobe Illustrator
Adobe Photoshop
Creation of the “Instructions for Use” with defined medical product milestones, such as certification, usability test, final version as well as long-term support for updating the IfU.