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    Framework of modern medical software development lifecycle

    MEDICAL DEVICES

    This two-day training is intended for medical software manufacturers and goes through the development of medical software in the IEC 62304 framework. The training provides the participant with a vantage point for software development in a medical environment as well as a strong understanding of quality issues and related terminology. Training improves communication between quality and software people and thereby enhances the development of compliant and high-quality software. This training is also MDR and IVDR compliant.

    MD-software-21-768x633

     

    Topics of this session


    DAY 1 

    SDLC in general 

      • Project documentation
        – Product is larger than the software
      • QMS Standard requirements on the SDLC – review steps are the constraints
      • waterfall vs agile (Scrum/Kanban/XP/SAFe)
      • Agile gives speed + DevOps gives safety

    Medical SDLC + QMS

      • 62304 + 82304 overview
      • Terminology
      • Mapping of 62304 to waterfall and Scrum
      • Performed activities and expected outputs
      • Mapping to 13485 phases and mandatory reviews
      • SOUPs

    Day 2 

    SDLC with Git and Scrum 

      • Ways of producing documentation: stand-alone vs embedded
      • Enforce quality gates – Pull requests
      • Tooling: requirements, code changes, configurations, CI/CD pipelines, test results, artifacts, releases, deployments
      • Configuration management: software decomposition, SOUP registry, development tools

    ALM tools

    Workshop

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    Trainers

    Mika Siitonen
    Mika Siitonen
    Head of Digital Health
    mika.siitonen@aurevia.com
    Mika is a business-orientated expert in software-driven medical devices and product registrations with over 15 years of experience in project management, R&D, and testing from the medical device field as well as other industries. He has a broad understanding of design control, testing methodology and its development, data visualization and statistical analysis. In his duties, Mika has specialized in software registrations and the new medical device regulation on software products.
    Vlad Știrbu
    Vlad Știrbu
    Software and RegOps Specialist

    Target group

    Personnel working with medical software, such as developers, testing personnel, quality personnel.

    After this session, you

    • have knowhow how to utilize IEC 62304 is software development
    • understand linking between ISO 13485, IEC 62304 and cyclical lifecycles.
    • understand terminology used in medical software development

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    Billing and cancellation policy

    Read the billing and cancellation policy for online trainings here.

    Participation in the training can be cancelled two weeks (14 days) before the event free of charge. For cancellations made after this, we will charge 50% of the participation fee, except for cancellations made one week before the event, we will charge a 100% participation fee.

    Cancellations are always made in writing to: koulutus@aurevia.com.  
    The participating organization may, if it wishes, change the participant free of charge by notifying it in writing before the event to:  koulutus@aurevia.com. The participation fee will be invoiced immediately after the event. The training session will be confirmed to the participant by e-mail about a week before the event.  Labquality reserves the right to cancel the training session due to a small number of participants.