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Risks Revealed • Quality Improved • Compliance Assured

AI-Powered Risk Management for Medtech

Synclytics uncovers hidden risks, drafts audit-ready files in minutes, and keeps every QMS/PLM document perfectly in sync.

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More comprehensive risk analysis

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Faster analysis and documentation

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Changes to existing QMS / PLM

Empowering medtech manufacturers to deliver safe, high‑quality products faster.

Synclytics is the AI engine that uncovers hidden risks and keeps every quality document in your QMS / PLM living and up to date. It drafts and updates risk and quality documents in minutes—delivering audit-ready files 15× faster. Enterprise medtech OEMs and top contract manufacturers rely on Synclytics to double risk coverage, accelerate approvals, and bring devices to market with confidence.

Qualtech Platform Interface

2× More Risks Identified

AI surfaces twice the failure modes, causes, and effects hidden in typical FMEAs.

15× Faster to Audit-Ready

Generate compliant first drafts in minutes, finalize in hours.

Seamless with Existing QMS/PLM

Sits on top of validated systems, no re-validation required.

Instant Change Propagation

Auto-suggests downstream updates so nothing slips through.

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Trusted by $1B+ medtech OEMs and CMOs to speed development and reduce risk.

Ready to reveal hidden risks?

Schedule a demo to see Synclytics generate audit-ready drafts in minutes.

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