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Transform quality into your brightest asset

QMS for Medical Devices

Accelerate from idea to market for medical devices

Controlled Printing & Reconciliation

21 CFR 11 compliant controlled printing

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Document Management

Ensure a digitalized, quality-driven approach

Training Management

Boost continuous learning

Quality Events Management

Reduce compliance issues and save time

CAPA Management

Streamline workflows to instill a quality culture

Change Control Management

Implement change faster

Audits Management

Remove stress and simplify compliance

Risk Management

Take away the dread and reduce the risks

Equipment Management

Ensure consistent maintenance

Quality KPIs

Enhance performance with quality metrics
Solutions
Industries

Pharma & Biotech

Digitalize, integrate, and automate all your quality processes

Medical Devices

Bring safe and compliant devices to market faster

Medicinal Cannabis

Boost efficiency to breeze through trial deadlines

CRO/CMO

Boost efficiency to breeze through trial deadlines

ATMP

Standardize and track all your manufacturing processes
Use Cases

Implementing a GMP-compliant QMS

Ensure quality and safety in all your products

Becoming audit ready

Stay audit-ready stress-free anytime

Streamline Design Control process

Achieve full traceability in Medical Device Development

Complying with GDP standards

Safeguard your supply chain with GDP compliance

Platform

What is Smart Quality?

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Calculate your custom ROI

Curious about the ROI of implementing an eQMS?
Get your ROI figure
Resources

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Smart Quality Summit 2024

Discover the fifth wave of quality

Glossary

Increase your quality terminology

2024 Quality Outlook

Stay at the forefront of the latest trends

Scilife Academy

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Smarty

Medical Devices chatbot powered by AI

Quality Management Soft Skills

Master the essential soft skills for a resilient, quality-driven life sciences team

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Top 10 FAQs about Performing Risk Management under MDR/IVDR

Recently, our Scilife CEO Filip invited Mika Siitonen, Medical Development Manager at Labquality and seasoned expert in medical device regulatory guidelines, to answer anything and everything you wanted to know about performing Risk Management under ...

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