MedTech teams pour energy into R&D. But when audits and regulatory submissions loom, compliance gaps surface: scattered docs, unrecorded design decisions, missing traceability, turning design control into a frantic catchup game that risks costly delays and failed submissions. In this live demo, Scilife Product Specialist Laura Gilbert, and Knowledge Manager Angel Buendía will show how Scilife’s Design and Development helps you organize design controls, ensure traceability and avoid compliance walls.
You’ll learn how to:
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Streamline design control documentation in line with ISO 13485:2016 and FDA 21 CFR Part 820.
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Spot gaps instantly with an auto-generated traceability matrix.
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Ensure proper approvals at every stage with 21 CFR Part 11-compliant e-signatures.
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Manage reviews, keep teams aligned, and prevent delays with automated notifications and approval workflows.
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Track changes, compare versions, and maintain a complete audit trail for full transparency.
