SciNote ELN

Streamline Device Development and Compliance

This platform is designed for medical device companies and R&D organizations, offering a comprehensive electronic lab notebook (ELN) and lab management system. It supports documentation, inventory tracking, SOP management, and workflow automation, enabling teams to accelerate innovation while maintaining regulatory compliance and design traceability.

Key Benefits

• Save time and simplify multi-phase R&D workflows from design through approval.
• Maintain complete records linking inputs to outputs and design changes.
• Align with international standards and reduce audit preparation time.
• Enable secure, role-based access across departments and locations.
• Generate structured and submission-ready design documentation.
• ISO 27001:2022-certified security with full trace logs and change tracking.

Features

The platform provides a user-friendly interface that centralizes data, making it easy to organize experiments, tasks, and specific steps. It allows for seamless task sharing and assignment, improving team coordination and eliminating repetitive rewriting by duplicating experiments with only key adjustments needed.

It supports advanced medical device and digital health innovation, facilitating rigorous development processes, cross-functional collaboration, and audit-ready documentation. The platform helps teams stay aligned across design, research, and validation phases.

Functionalities

Securely capture lab notes, usability testing data, biological assessments, and analytical studies in a structured, searchable ELN environment. Organize data in a structured way and customize the platform based on lab processes. Manage protocols in a centralized repository and use advanced search to quickly locate data.

Ensure design traceability and audit readiness by linking design inputs, user needs, risk analyses, test plans, and results through each design iteration. The platform supports Design History File (DHF) and Technical Documentation management, with secured system-login and unique electronic signatures for each user.

Verification and validation support includes documenting protocols and results for software testing, mechanical reliability, biocompatibility, and performance verification in an audit-ready format. Create templates with repeatable tasks and workflows, assign tasks, set due dates, and monitor progress on the dashboard.

Track components, devices, consumables, and test builds with real-time links to associated documents and test records. Manage lab inventory, visualize location, track usage, and receive alerts for low stock or scheduled activities. Import and export inventories between Excel and the platform.

Connect engineers, regulatory professionals, scientists, and QA teams through controlled-access project spaces with full activity logs. Engage in real-time communication, tag colleagues, post comments, and follow notifications to keep everyone informed and aligned.