Design and Development tool

Scilife's medical device product development software is designed to simplify design controls and maintain compliance effortlessly. It enhances traceability, speeds up audit readiness, and eliminates the inefficiencies that hinder QA and product teams. This platform is trusted by leading medical device organizations for its ability to streamline workflows and reduce time to market.

The software provides an automated traceability matrix that connects design controls in a single view, making it easy to track changes, compare versions, and manage approvals with compliance electronic signatures. It supports compliance with ISO 13485:2016, EU MDR, and FDA 21 CFR 820 requirements.

Bringing a medical device to market involves navigating multiple design and development stages before regulatory approval. The software addresses delays caused by human errors or missing documents, helping teams get to market faster with audit-ready capabilities.

Key Features

• Structured, compliant workflow for medical device teams
• Visual workflow for navigating design control processes
• 3-step approval cascade with 21 CFR Part 11 electronic signatures
• Instant audit-ready report generation for internal and external reviews
• Real-time traceability with a built-in traceability matrix
• Version comparison tool for tracking changes

The platform ensures end-to-end traceability by automatically connecting user needs, design inputs, outputs, verifications, and validations. It allows users to view, add, update, or delete design controls directly from the matrix, quickly resolving traceability gaps.

For audits and team reviews, the built-in version comparison tool provides a clear record of changes, supporting transparency across the design process. Users can export traceability matrices, audit trails, and design control lists to Excel or CSV for compiling technical documentation.

Scilife's solution also supports IEC 62304 compliance by documenting software lifecycle activities, with additional documentation managed through the Change Control tool. The platform offers various user roles, including creators, responsible persons, reviewers, and QA, each with specific responsibilities in the project workflow.