Functional Safety

Functional Safety of Medical Devices

The aim of functional safety is to design medical devices in such a way that any probable technical defect is detected in advance and does not pose a hazard. In this course you will learn about the standards applicable to functional safety, understand the basic principles of functional safety, and how to apply that knowledge to the development of your medical devices.

Building on this, we will provide you with knowledge on the subject of computer safety and automatic self-tests of computer components. You will learn about the challenges of selecting and implementing the right techniques for the respective application.

  • You will acquire knowledge of the standards for functional safety of medical devices.
  • You will achieve increased product safety within the development processes of your medical devices.
  • You avoid risks to patients.
  • You develop according to the state of the art and reduce liability risks.

  • 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

  • Manufacturers of active medical devices
  • Developers (hardware and software) of all medical devices
  • Employees and managers from research and development
  • Quality managers, regulatory affairs

Course Outline
  • 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


Basic knowledge of main standards in medical devices.

Job Interview Question Answers

International Fee: 650USD

Flexible Class Options

  • Week End Classes For Professionals  SAT | SUN
  • Corporate Group Trainings Available
  • Online Classes – Live Virtual Class (L.V.C), Online Training

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Flexible Classes Schedule

Online Classes for out of city / country students

Unlimited Learning - FREE Workshops

FREE Practice Exam

Internships Available

Free Course Recordings Videos

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