Medical Device Software in Europe

Training Course

Course Details

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

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Learning Objectives

  • Understand regulatory requirements applicable in Europe for standalone software as medical device and to medical devices incorporating software
  • Identify and understand classification rules applicable to software in MDR and IVDR
  • Provide practical examples of Risk Management and Clinical Evaluation linked to software
  • Walkthrough on Software Life Cycle Management (IEC 62304 e IEC 82304-1) and Cybersecurity
  • Gain understanding in safe software development for medical devices
  • Technical Documentation for standalone software medical devices and medical devices incorporating software

Who will benefit?

Software developers, software architects, quality managers, regulatory managers, user interface designers, system designers, consultants.

Course Agenda

  • European regulatory requirements for standalone software medical devices and medical devices incorporating software
  • When a software is a medical device in Europe
  • Medical device software classification according to MDR and IVDR:
    • MDR/IVDR Annex VIII
    • MDCG 2019-11 Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR
    • MDCG 2020-16 Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746
  • Software Life Cycle
    • IEC 62304:2006+AMD1:2015
    • IEC 82304-1:2016
  • Clinical Evaluation for MDSW
    • MDCG 2020-1 Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software
  • Cybersecurity
    • MDCG 2019-16 Cybersecurity
    • AAMI TIR 57 and IEC DTR 60601-4-5
    • Confidentiality, Integrity, Availability
    • Threat Modelling
  • Risk Management for standalone software medical devices and medical devices incorporating software
  • Technical Documentation for standalone software medical devices and medical devices incorporating software
    • What needs to be documented
  • Examples and practical interactive workshops
  • Final exam (optional)

Prerequisites

Basic knowledge of medical devices regulatory framework and ISO 13485:2016.

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

Duration

8 hours.

Scheduled Events

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

Price

950,00 € (per participant, taxation excl.).

Learning Mode

Online, Instructor-Led

Language

Training in English Language

Book now
or contact us at [email protected]

 

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