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Kontakt zu unserem Schulungsteam
koulutus@aurevia.com+358 9 8566 8200
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Inhalt
DAY 1
SDLC in general
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- 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
- Project documentation
Medical SDLC + QMS
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- 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
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- 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
Trainer
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.
Zielgruppe
Personnel working with medical software, such as developers, testing personnel, quality personnel.Nach diesem Training
- 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