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GitLab as quality management system for ISO 13485

The international standard ISO 13485 defines the requirements for the design, manufacture and marketing of medical devices. GitLab offers many functions and controls that can be used to meet the requirements of ISO 13485.

Note

The information provided on this website is for informational purposes only. This information is not legal advice. It’s not comprehensive and does not in itself guarantee compliance with ISO 13485. To achieve ISO 13485 compliance, we recommend consulting with specialists.

Create and manage documentation

The GitLab Wiki can be used as a documentation system. Wiki pages can be created and managed via a user-friendly web interface or Git for advanced users. A complete history is guaranteed via version management with Git.

Define and enforce processes

GitLab provides several tools for enforcing processes, standards, reviews and approvals:

  • Permissions for merge requests can be used to enforce review of changes before merging.
  • Protected development branches can be used to define rules for creating, moving and deleting.
  • Requirements management can be enabled in a structured way using issues, labels and relations, with processes enforced and reviewed in a traceable way.

Software validation according to ISO 13485

For the validation of QM software, procedures for the evaluation have to be created. GitLab facilitates this via templates within you can upload forms and other files, create task lists and much more. All actions, including changing the description or commenting, are logged.

Task lists and Kanban boards provide an easy way to organise validation.