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

Challenge

In the medical device industry, speed means nothing without early compliance.

Yet many companies still operate with disconnected systems, where product teams move ahead while QA is looped in too late. 

The result: fragmented documentation and unclear traceability.

Eventually, progress slows to a halt. Teams hit the compliance wall—facing rework, delays, and rising regulatory risk.

Solution

No more silos, no more delays.

Scilife’s Design Control software connects product and quality teams from the start.

Structured workflows and automated traceability simplify documentation and give teams clear visibility into user needs, inputs, outputs, verifications, and validations.

That means compliance on track and innovation moving forward.

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.