Associação Fraunhofer Portugal Research

Support in post-marketing clinical follow-up aimed at ensuring the safety and performance of the device throughout its life cycle, which includes identifying possible adverse events and contraindications, potential misuse and off-label use, and evaluating the acceptability of the risk-benefit ratio.

General guidelines illustrating best practices for the implementation and development of software as a medical device with artificial intelligence models, aligned with current regulatory guidelines such as the AI Act, ISO 13485, and ISO 42001.

Support service for planning, implementing, and finalizing usability studies, with documentation support, adapted to Medical Device Software, in accordance with the IEC 62366 standard.

Training on preparing the Investigator Brochure, covering its constituent elements according to ISO 14155:2020. The Investigator Brochure is an essential and mandatory document for the submission and approval of clinical studies with medical devices, and some of the information contained therein is also required for submission in medical device certification applications.

Training in the preparation of a Clinical Investigation Plan for clinical research on medical devices. This is an essential document for researchers in research centers throughout the study and is a mandatory document in submissions to the CEIC and Infarmed.

Support in preparing the Investigator Brochure, addressing its constituent elements, according to ISO 14155:2020. The Investigator Brochure is an essential and mandatory document for the submission and approval of clinical studies with medical devices, and some of the information contained therein is also required for submission in medical device certification applications.

Support in the preparation of the Clinical Investigation Plan for clinical research on medical devices. This is an essential document for researchers at research centers throughout the study and is a mandatory document in submissions to the CEIC and Infarmed.