Subject Training

Background: The PhotoVivo research platform is a CRAN platform, a joint research unit of the CNRS and the University of Lorraine. Two members of staff work on the platform: the Quality Manager (Clarice Perrin-Mozet) and the Scientific Manager (Marine Amouroux). Some CRAN members working on the platform design and develop innovative medical devices based on spectroscopy and optical imaging technologies. The platform's staff have notably developed the SpectroLive device, designed to assist in the diagnosis of skin carcinomas. This device has already undergone a clinical study, which has led to the creation of a database and the development of diagnostic assistance software. This software enables communication with the data acquisition software as well as real-time signal processing and analysis. It also displays diagnostic assistance information (probability of cancer risk) with associated risk levels. In addition to developing innovative medical devices, the PhotoVivo platform staff provide scientific services, contribute to applied research projects, teach or train students in the use of equipment, provide equipment, and contribute to the scientific promotion of the platform's activities (oral presentations, publication of articles). The SpectroLive system is one of the platform's major projects. The platform already has a quality management system (QMS) structured according to the INFRA+ standard internal to the University of Lorraine. This standard is inspired by the ISO 9001 standard, but does not address all of the requirements. Risk management is notably lacking. As part of the development, clinical, and regulatory promotion of SpectroLive (or other medical devices in the future), the platform wishes to implement a quality management system (QMS) compliant with the ISO 13485 standard, the international standard for medical devices.

Internship Objective: Contribute to the development, structuring, and implementation of a QMS compliant with ISO 13485, in connection with the development and clinical evaluation of the SpectroLive medical device.

Duties: Working with and reporting to the platform's Quality Manager, the intern will participate in the implementation of a quality management system compliant with ISO 13485, specifically dedicated to the SpectroLive project, an innovative medical device developed within the PhotoVivo platform. This quality system may also be used for future medical device developments within the platform. The internship will focus on drafting the quality manual, creating procedures and reference documents (instructions, records, forms), and formalizing processes related to product quality management: design, validation, traceability, versioning, document management, etc. The intern will also consult existing quality documentation related to the device's software component to understand the functional architecture (program sequence, role of scripts, file types, etc.). This will not involve developing software, but will instead involve identifying the roles of software modules in the data processing chain and documenting their function in the QMS. They will also contribute to implementing quality management tools, defining relevant indicators, and structuring risk management according to the principles applicable to medical devices. They will work closely with the platform team and participate in raising team awareness of the specific requirements of ISO 13485. It is important to note that the PhotoVivo platform conducts a variety of activities beyond the development of medical devices: services, research projects, equipment provision, training, and scientific promotion. The ISO 13485 QMS will therefore only concern a specific aspect of its activity, and will be integrated into a multidisciplinary environment.