Design Approach of Medical Devices for Regulation Compatibility: A Robotic Rehabilitation Case Study

Abstract

Regulations and normative framework strongly affect requirements and potential design constraints of devices, especially in critical environments like the medical field, characterized by a complex interaction among design, therapy procedures and user needs. In order to optimize the design process, the awareness of the designer about the compound information net generated by the required documentation becomes therefore fundamental. Depicting a custom mapping of required data and referring documents for the development and commercialization of a medical device as required by the Conformité Européenne (CE) marking process, this paper presents a design approach directly suitable for robotic rehabilitation systems, which aims at easing the regulations compatibility of the designed product. This method is applied to the illustrative case study of the LEPRE (LEg Programmable REhabilitation) robotic system, with particular attention to data collection and analysis for the evaluation of clinical background and demonstration of equivalence required by the device clinical evaluation report, according to MEDical DEVices (MEDDEV) 2.7/1 guidelines. Indications for the modifications required to adapt it to further application fields are also suggested.