Medical devices

Ensure that all BOM components, designs, and documentation remain consistent and aligned with the last approved configuration. Improve quality and accelerate innovation with complete visibility into developments.

Manage each stage of product development by integrating regulatory requirements from the design stage. Centralize tasks, deliverables, schedules, and resources in a single platform. Improve collaboration between teams and simply track the progress of your projects to meet deadlines, anticipate risks, and speed time to market.

Ensure the traceability of changes in processes and documentation throughout the product life cycle. Ensure regulatory compliance (ISO 13485, FDA 21 CFR Part 820, MDR, IDVR) and simplify audit management.

Ensure confidentiality and have precise control over who can view, edit, or validate product data based on roles and responsibilities. Secure your data to improve collaboration and benefit from the complete traceability of actions to ensure compliance with regulatory requirements (ISO 13485, FDA 21 CFR Part 820, MDR, IVDR).