Functional Safety for Medical Devices

Course Details

Event Scheduled: On request
Learning Mode: Online
Language: English
(see more details below)

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Learning Objectives

• Provide basics concepts for Functional Safety in Medical Devices
• Gain competences on application of Functional Safety in Medical Devices, with examples and practical workshops
• Illustrate normative/standard regulatory background to Functional Safety in Medical Devices
• Understand Single Fault Condition concept, as it is defined in IEC 60601-1
• Understand different possible failure categories in a Medical Device
• Evaluate possible system architectures (control, protection) and specific peculiar aspects
• Define an approach to validate Functional Safety aspects
• Identify main contents related to Functional Safety within Medical Device Technical Documentation

Who will benefit?

Active medical device designers, risk management owners, quality managers, regulatory affairs managers.

Course Agenda

• Introduction: General background and normative/standard context applicable to Medical Devices
• What is Functional Safety
• Risks included in Functional Safety concept, brief overview of Risk Management in Medical Devices
• Ultimate goals of Functional Safety concept
• Single Fault Condition definition and concept
• Failures
• Probabilistic model of failures
• How many failure to consider
• Which failure to consider
• How to protect from failure modes: redundancy and diversity
• How to develop a Functional Safety model
• How to identify important timings and why
• Analysis of control and protection architecture models
• Pros and cons
• Timing dynamic modelling
• System approach to Functional Safety
• Technical Documentation about Functional Safety
• What needs to be documented
• Examples and workshops
• At the end of the training there will be a (voluntary) Final Test

Prerequisites

Basic knowledge of main standards in medical devices.

Course Materials

• Handout, containing the slides projected during the course, in case of online courses it will be provided in electronic format;
• Workshop schemes
• 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 UNI store http://store.uni.com/catalogo/index.php/ or request a copy within their own organisation.

Learning Assessments

• Competence attestation, when final test is positively completed
• Attendance attestation, when final test is not completed or target is not met

Duration

8 hours.

Scheduled Events

• Events will be planned on request (and published on this page).

Price

1.050,00 € (per participant, taxation excl.).

Learning Mode

Online, Instructor-Led

Language

Training in English Language

or contact us at [email protected]