Stay ISO 13485 and 21 CFR part 820 compliant with smart design control software

Challenge

Medical device companies often manage quality with multiple, unconnected systems, leading to a fragmented approach.

These non-scalable systems make it hard to keep development and quality teams aligned and adapt to new regulations and market demands as companies grow.

Solution

Accelerate product development and ensure seamless design control with Scilife Smart QMS software for medical devices.

Gain full oversight with an automated traceability matrix, version control, and compliant electronic signatures—ensuring regulatory compliance while streamlining workflows.

What’s in it for your quality team?

No more chasing evidence or playing catch-up. Audit readiness becomes a byproduct of the process, not a last-minute fire drill.

Get full visibility into design controls from day one, with every input, output, verification, and approval documented, linked, and traceable.

What’s in it for your product team?

Stay focused on development while your work automatically feeds into a structured, audit-ready system.

Avoid costly rework, project delays, and unexpected compliance issues by aligning with QA from the very beginning.  It’s design control that moves as fast as you do, supporting innovation, not slowing it down.