Scheduled Events: July and October 2025 Learning Mode: Online Language: English (see more details below)
Richiediamo il tuo consenso per poter caricare i video di YouTube. Se acconsentirai, verrà visualizzato il contenuto esterno e i tuoi dati personali potrebbero essere trasmessi a piattaforme di terze parti e a paesi terzi non sicuri. Per abilitare il servizio e dare il consenso, clicca su "Visualizza video". Puoi revocare il consenso in qualsiasi momento dal menù dei cookies. La revoca del consenso non pregiudica la liceità del trattamento avvenuto prima della revoca. Per maggiori dettagli, consulta linformativa privacy (link in fondo alla pagina).
Richiediamo il tuo consenso per caricare i video di YouTube. Questo servizio utilizza cookies che vengono impostati al momento del caricamento e i dati personali potrebbero essere trasmessi a piattaforme di terze parti e a paesi terzi non sicuri. Per abilitare il servizio e dare il consenso, clicca su "Gestisci le impostazioni dei cookies" e abilita i cookie di pubblicità mirata, quindi procedi. Puoi revocare il tuo consenso in qualsiasi momento dal menù dei cookies. La revoca del consenso non pregiudica la liceità del trattamento avvenuto prima della revoca. Per maggiori dettagli, consulta le informazioni sullinformativa privacy (link in fondo alla pagina).
Learning Objectives
Understand regulatory requirements applicable in Europe for standalone software as medical device and to medical devices incorporating software
Identify and understand classification rules applicable to software in MDR and IVDR
Provide practical examples of Risk Management and Clinical Evaluation linked to software
Walkthrough on Software Life Cycle Management (IEC 62304 e IEC 82304-1) and Cybersecurity
Gain understanding in safe software development for medical devices
Technical Documentation for standalone software medical devices and medical devices incorporating software
Who will benefit?
Software developers, software architects, quality managers, regulatory managers, user interface designers, system designers, consultants.
Course Agenda
European regulatory requirements for standalone software medical devices and medical devices incorporating software
When a software is a medical device in Europe
Medical device software classification according to MDR and IVDR:
MDR/IVDR Annex VIII
MDCG 2019-11 Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR
MDCG 2020-16 Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746
Software Life Cycle
IEC 62304:2006+AMD1:2015
IEC 82304-1:2016
Clinical Evaluation for MDSW
MDCG 2020-1 Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software
Cybersecurity
MDCG 2019-16 Cybersecurity
AAMI TIR 57 and IEC DTR 60601-4-5
Confidentiality, Integrity, Availability
Threat Modelling
Risk Management for standalone software medical devices and medical devices incorporating software
Technical Documentation for standalone software medical devices and medical devices incorporating software
What needs to be documented
Examples and practical interactive workshops
Final exam (optional)
Prerequisites
Basic knowledge of medical devices regulatory framework and ISO 13485:2016.
Course Materials
Handout, containing the slides projected during the course, in case of online courses it will be provided in electronic format;
Notebook for didactic use (where applicable), containing a copy of the standards necessary for the training course, to be returned at the end of the course. In order to respect copyright, all the standards of online courses can be provided for consultation only through access to a dedicated portal. For a higher quality of teaching and preparation for exams (where applicable) it is advisable that participants purchase the reference standard directly from the official ISO store https://www.iso.org/home.html or request a copy within their own organisation.
Learning Assessments
Certificate of competence, in case of successful completion of final exam
Certificate of attendance, in case of non successful completion of final exam or no exam
