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+600 Corsi di formazione +130.000 Partecipanti all'anno in tutto il mondo Docenti esperti e qualificati
Certificati accreditati e riconosciuti a livello internazionale
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Scheduled Events: May 2026 Learning Mode: Online Language: English (see more details below)
Learning Objectives
Provide the basics concepts of Cybersecurity in Medical Devices
Identify the regulatory framework applicable to cybersecurity: MDR / IVDR, FDA Guidance (Pre- & Post-Market), Recommendation from German Federal Office for Information Security
Understand the content of International Standards: IEC 81001-5-1. AAMI TIR 57, IEC 62443, ISO / IEC 27001, IEC 60601-1, IEC 80001-1
Deepen general concepts such as: Identify, Protect, Detect, Respond and Recover
Acquire skills in Security Risk Analysis, in relation to the Risk Analysis of EN ISO 14971
Provide principles for the development of secure software.
Identify the main contents of the Technical File of a Medical Device related to Cybersecurity.
Who will benefit?
Medical Device Manufacturers containing software or stand-alone software, Quality Management and Regulatory Affairs Managers, Software and Systems Designers, Interface/Usability and Requirements Designers, Medical Device IT Service Providers.
Course Agenda
Introduction: General overview of the international legislative and regulatory context applicable to Medical Devices
What is Cybersecurity
What are the risks it deals with
What are the objectives of cybersecurity: Confidentiality, Integrity, Availability
Regulatory Requirements
IEC 81001-5-1
AAMI TIR 57
Guidance FDA
IEC 62304
Recommendation for networkable medical devices (BSI)
IEC 80001
Other standards and guidelines
How Risk Management according to ISO 14971 relates to Cybersecurity
Probability estimation
Analysis of IT communication channels
assets
vectors
threats
vulnerabilities
The content of the Technical File regarding cybersecurity
What to document
Examples and practical exercises
Prerequisites
Basic knowledge of regulations and standards in the field of medical devices.
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.
