WP7 - Regulatory Affairs and Quality Assurance
The overall objective of this work package is to ensure compliance with all legal requirements in our research involving humans and focuses on the maximum patient's safety during the RASimAs evaluation (WP6). This includes particularly the production of Technical File (TF), Investigator's Brochure, Clinical Trial Protocol including Patient Information and Informed Consent Form and Electronic Data Capture System for a multi-center, multinational clinical trial (CT) in Germany, Ireland and Belgium. The evaluation of the assistant system is planned to be a highly regulated Phase Ib/IIa clinical trial according to the European Medical Device Directive and will be designed to assess safety and proof-of-principle of the RASimAs assistant system prototype in patients scheduled for surgeries requiring RA. The partners involved in this work package are already experienced in the development of software (embedded or stand-alone) and have each implemented Quality Management Systems. The preparation of the TF will ensure compliance with the relevant directives, guidelines and normatives such as Medical Device Directive (MDD, 93/42/EEC, 2007/47/EG, the national acts on medical devices, DIN EN ISO 13485, DIN EN ISO 14971, DIN EN ISO 62366, DIN EN ISO 62304. Under the guidance of the consortium leader the interfaces between all contributions of the partners to the prototypes (hard- and software) will be analyzed, evaluated and documented.