CamiTK provides a SDK and applications in order to support the maturation cycle of your Computer Assisted Medical Interventions
Applications or Medical Devices.
Using the C++ SDK, the CamiTK Wizard and the CamiTK virtual workbench (called CamiTK imp) you can quickly design new algorithms or new process in order to shape the concept product. Once your proof of concept is defined, CamiTK provides another type of application (called the CamiTK action state machine) to test your prototype over a great number of cases.
The following image, greatly inspired and reproduced by courtesy of MAXITHEC Center of Clinical Investigation - Innovative Technonology, shows the maturation cycle of a new medical device and the associated innovation spiral.
CamiTK has to be considered as off-the-shelf (OTS) product for supporting a higher level medical application/product. The developer of such application/product will be responsible for performing the validation processes described in FDA published guidelines or CE normalization process for the development of software-related medical devices.
CamiTK is intended to be used as elements in medical applications, those medical applications are the ones that can be subject of an FDA approval / CE normalization. Whoever develop such applications has the responsibility of validating their application in order to demonstrate that it is appropriate for the advertised purpose.
For example, if you develop an application for radiation treatment planning based on CamiTK, it is your responsibility to validate that application. In the process you will have to validate that the use you make of CamiTK satisfies the requirements of your application. You will probably be using a limited set of CamiTK functionalities in such application, therefore what you have to demonstrate is that those specific CamiTK functionalities are behaving as expected in the context of your application.
Note that not only you need to validate the use of CamiTK, but also the use of any other off-the-shelf (OTS) software product used in the development of your application. That will included things like:
- Your operating system
- Your compiler
- Your OpenGL library/drivers
- Any other library that your application is linking to.
- Even your processor
It is worth to point out that the Software Development Process using in CamiTK are already following many of the FDA Guidelines / CE normalization for software developement. In particular:
- Continuous Integration Testing via Dashboard (CTest-CDash)
- Version control (SVN)
- Configuration standarization (CMake).
- Bug tracking (BugZilla)
For details on the FDA Guidelines / CE normalization for development of software for medical devices you must look at the following documents: :
- [PDF] The international standard IEC 62304
- ISO and IEC standards for software in medical devices in a nutshell.
- Off-The-Shelf Software Use in Medical Devices
- [PDF] Guidance for the Submission Of Premarket Notifications for Medical Image Management Devices
- Guidance for FDA Reviewers and Industry Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
- [PDF] Guide général pour la mise sur le marché de dispositifs médicaux sur mesure