Healthcare
SPC Software for Medical Device Manufacturing
Medical device and healthcare product manufacturing leaves no margin for error. SynergySPC gives your team the real-time data, traceability, and documentation needed to meet the tightest tolerances and stand up to an audit.
Precision That Protects Patients
In medical device manufacturing, tight tolerances aren’t just a specification; they protect patient safety. Every characteristic your team measures needs to be documented, traceable, and ready for the customer or the regulatory audits that come with the territory.
- Tight tolerances on components machined from precision metals and medical-grade plastics
- Frequent customer audits, often monthly, require capability and run charts before shipment
Real-Time Control, Audit-Ready Documentation
SynergySPC gives your team real-time monitoring, so parts stay in specification at every step of the process, plus the capability and run charts your customers and auditors ask to see. Synergy 2000 and Synergy 3000 also meet FDA 21 CFR Part 11 requirements, with electronic signatures and required data documentation, so your records hold up to scrutiny.
- Real-time analysis available the moment an operator enters data, even across multiple locations
Ready for a Monthly Audit
Veridiam, one of the world’s largest contract manufacturers of precision components for the medical, dental, and industrial markets, uses Synergy to keep its tightest tolerances in specification.
Monthly
Customer Audits
“ We have customer audits frequently, on average once a month, and some customers require capability and run charts prior to shipment. We use Synergy to provide real-time analysis of the production process as well as capability and run charts for them to review, ”
Whitney Ginter, Quality Manager for Veridiam
SPC Readiness Quiz
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SPC Readiness Quiz
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Built for How You Work
Ready to see how real-time SPC fits your medical device manufacturing line?