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.
Upcoming trainings
The next training date is not yet confirmed. Please inquire for more information.
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Topics
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
Trainers
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.
Target group
Personnel working with medical software, such as developers, testing personnel, quality personnel.Objectives
- 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