Design Control

Stay compliant with ISO 13485 and 21 CFR part 820 using a smart design control software that centralizes all design control documentation in one space. This solution helps avoid the compliance wall by ensuring early compliance, which is crucial in the medical device industry where speed without compliance can lead to fragmented documentation and unclear traceability.

Scilife’s Design Control software connects product and quality teams from the start, eliminating silos and delays. It offers structured workflows and automated traceability, simplifying documentation and providing clear visibility into user needs, inputs, outputs, verifications, and validations. This ensures compliance is on track and innovation continues to move forward.

Complete Toolset

Manage your medical device effectively by integrating with other Scilife tools such as Documents, Records, Events, CAPAs, and Change Control.

Streamlined Compliance

Ensure compliance with ISO 13485:2016 and FDA 21 CFR 820 through proper approvals using 21 CFR Part 11 electronic signatures. The software provides an automated traceability matrix, allowing you to see the status of your project at a glance and easily spot gaps in requirements.

Key Features

• Clear and comprehensive traceability at every stage, enabling effortless tracking of design controls and identification of gaps in the traceability matrix with a single click.
• Generate accurate, up-to-date, and audit-ready reports in seconds using out-of-the-box templates built on industry best practices, eliminating the need for manual design or configuration.
• Track workflow progress with transparent visibility into reviews, approvals, and bottlenecks, ensuring each requirement undergoes proper approval with 21 CFR Part 11 compliant electronic signatures.
• Improved version control allows for analysis of project changes by comparing prior versions with the current one, providing valuable insights during audits.

By bringing QA and product teams together from day one, the software ensures that audit readiness becomes a byproduct of the process, not a last-minute task. Quality teams gain full visibility into design controls, with every input, output, verification, and approval documented, linked, and traceable. Product teams can focus on development while their work automatically integrates into a structured, audit-ready system, avoiding costly rework, project delays, and unexpected compliance issues.