Design and Development
Services provided by CIMTEC:
Image Processing: Customized, clinically-validated image processing algorithms for rapid segmentation, registration and classification.
3D Visualization: Clinical graphical user interface (GUI) development, multi-modal 3D imaging and real-time quantification.
Mechatronics Design: Design and manufacture of prototypes with expertise in motion control and image-guided interventions.
Systems Design: Ensure that systems integrate smoothly into clinical workflow with attention to training requirements, impacts of pathology process developments and optimizing performance for time savings.
Project Management: Provide knowledge, skills and techniques to execute projects effectively and efficiently.
Introduction to Quality Management Systems (QMS): Provide information to individuals with companies who will be involved in developing, implementing or managing a QMS based on ISO 13485 and IEC 62304 standards.
This is a critical phase in the development of a successful product. If the design of the hardware and/or software is flawed with respect to effectiveness and safety, it can prevent the device from being approved or cleared by a regulatory body.
Design and development of a medical device is an iterative process. It can take several years to reach the point when the device is ready for clinical testing. It is important to ensure that the end product works as specified and will meet customer, as well as regulatory requirements. If the design does not meet customer or regulatory requirements, you may have to circle back and produce additional prototypes, a costly and time-consuming process.
While designing the device, customer specifications and the intended use for the device must be identified and incorporated into the end product. Any tests that will be conducted for verification and validation should also be designed during this phase. After the design is complete, a prototype is developed.