exida Trainings

 

Medical Device Development for Safety Engineers (DE0402)

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Category
Medical Device Development
Date
Thursday, 27 April 2023 10:00 - 18:00
Venue
Prof.-Messerschmitt-Straße 1, 85579 Neubiberg, Germany
Email
This email address is being protected from spambots. You need JavaScript enabled to view it.
Instructors
Tim Jones
Type of training
Online or by presence
Brochure

Medical Device Development for Safety Engineers

 

Agenda and Content

  • Recap - Introduction for Functional Safety
  • Regulatory Basics and Legal Aspects for Medical Devices
    • Standards, Regulations and their Interactions, such as:
    • Device and Safety Classification
  • Essential Performance and Basic Safety
  • Single Fault Safe Systems - Single Fault Conditions
  • Creating a safety argument based on key techniques to handle Functional Safety in Medical Devices
    • Risk Management Lifecycle
    • Architecture, Design and Safety Design Patterns
    • Verification and Validation
    • Safety Analyses
  • Impact of Artificial Intelligence and Machine Learning to Functional Safety

Who should attend?

Safety engineers, who want to learn more about safety related medical device development, such as:

  • Safety Managers and Project Managers
  • Development and Safety Engineers (System, HW and SW)

Basic experience in functional safety is beneficial.

 For more details about the course topics, download the brochure on the top of the page

 
Duration:    1 day
 
Schedule:    from 10.00 to 18.00;

Language:   English or German in agreement with the participants. The training material will be in English.

Location:    ONSITE at our training rooms to exida.com GmbH office, Prof. - Messerschmitt-Straße 1 - D-85579, Neubiberg / Germany or ONLINE

Certificate: Each participant gets a confirmation of attendance also listing all the covered topics.
 
 

Training - Calendar


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We provide consulting, assessment, cybersecurity, alarm management, product testing and certification under a number of Functional Safety, Security and SW Quality standards, such as IEC 61508, IEC 61511, ISO 26262, ISO 13849, IEC 62061, ISA Security Compliance Institute (ISCI), ASPICE


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