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OpenRegulatory Conference 2021

Dr. Johannes Tanne: Using git for QMS Document Control

Dr. Johannes Tanne, dentalXrai

Using git for QMS Document Control

Git can be used for the documentation process for medical device manufacturers, especially medical software manufacturers. The presentation will focus on the possibilities of using the version management tool to enable easy traceability and structured document control. As it is already used in the best practice of software development and is common standard in a good software development process.

The documentation not only enables the creation of markdown files, but also helps the user to easily version manage individual documents. This includes documentation from QM master documents, QM records to essential technical documentation records so that documents such as software architecture can be easily kept up to date by developer staff and are auditable for certification audits.

It will be shown how documentation can be realized from creation, review of documents and records to release.

Dr. Johannes Tanne is regulatory affairs manager/ QMR at dentalXrai GmbH. He completed his master's degree in the field of biosystems engineering/ bioinformatics and his doctorate in the field of bioanalytics at the Fraunhofer Institute for Biomedical Engineering. He has several years of experience in the field of quality management and regulatory affairs and has been working as a consultant for various medical device manufacturers for the last 7 years. He is an active member of the WHO working group FGAI4H and serves on the Special Committee AI (Artificial Intelligence) and X-ray Image Analysis of DIN.

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