Reference : 1.01.04.0018 (Inter-entreprise)
IEC 81001-5-1 Medical Standard Training
- 05/09/2025 -
Cybersecurity of Medical Devices
IEC 81001-5-1 Training Goal
This training provides an introduction to the cybersecurity approach applied to medical devices, describing the processes involved in the lifecycle of the medical device and its software, and the methodologies that can be used to meet regulatory and standards requirements relating to cybersecurity risk management.
At the end of the course, learners will be able to :
- Situate cybersecurity in the medical ecosystem and understand the relevant regulatory requirements
- Conduct a cybersecurity risk assessment
- Implement the requirements of IEC 81001-5-1
- Plan the detailed actions and checks to be carried out for each part of the DM lifecycle
- Select the tools required to conduct code audits
- Plan the response to a cybersecurity incident
Contact us
Email : formation@isit.fr - Tél : +33 561 306 900
IEC 81001-5-1 Training Duration
1 day (7 hours)
IEC 81001-5-1 Training Target Audience
This course is aimed at project or product managers, software developers, system architects, cybersecurity managers, internal auditors, regulatory and medical affairs managers.
IEC 81001-5-1 Training Requirements
General principles of systems and software engineering; knowledge of the quality assurance management system (ISO 13845) and the basic principles of risk management is desirable.
- Assessment methods : here
- Trainer: Experienced engineer in the fields of real-time embedded systems and industrial networks, accompanied by an expert on the IEC 81001-5-1 standard.
Training organization registered under number 73 31 04675 31.
This registration does not imply state approval. Art.L6352-12 du Code du travail Circ. N°2006-10 du 16/03/06
This registration does not imply state approval. Art.L6352-12 du Code du travail Circ. N°2006-10 du 16/03/06
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