A quality management system built for medical device and aersopace startups and small organizations. Paperless, compliant, and ready to scale.
Regulix eQMS is a cloud based electronic quality management system customized specifically for medical device startups or small organizations. It replaces paper- based processes and disconnected spreadsheets with a single compliant platform that keeps your team aligned and your auditors satisfied. Billed as a monthly subscription so you only pay for what you need.
Sound familiar?
"Our documents are scattered across shared drives and email threads."
Regulix 360 eQMS centralizes all your controlled documents in one place with version control, approval workflows, and audit trails built in.
"We track CAPAs and NCMRs in spreadsheets and things fall through the cracks."
Our system manages CAPAs and NCMRs with assigned owners, due dates, escalations, and automatic status tracking so nothing gets missed.
"We have an audit coming up and our training records are a mess."
Regulix 360 eQMS tracks training assignments, completions, and records for every team member so you can pull a full training report in minutes.
"We're growing fast and our paper based QMS can't keep up."
Regulix 360 eQMS is cloud based and scales with your team. Add users, documents, and modules as you grow without disrupting your existing processes.
Everything you need in one platform.
Built to meet ISO 13485 and FDA QMSR/21 CFR Part 820 or AS9100D and ISO 9001 requirements. Fully paperless, customized to fit your needs, and audit ready from day one.
Document Control
Centralized document management with version control, approval workflows, electronic signatures, and full audit trails.
Nonconformance (NCMR)
Log, investigate, and disposition nonconforming materials and products with full traceability from identification through resolution.
Change Control
Structured change request and approval process to manage design, process, and document changes with full traceability.
Audit Management
Plan, execute, and track internal and supplier audits with findings management, corrective action linkage, and audit report generation.
CAPA Management
End to end corrective and preventive action management with root cause analysis, action tracking, effectiveness checks, and closure documentation.
Training Records
Assign, track, and document training for every team member. Pull complete training records instantly for audits and inspections.
Why startups choose Regulix 360 eQMS.
Built for medical device
Designed specifically for ISO 13485 and FDA QSMR/21 CFR Part 820 or AS9100D and ISO 9001compliance. Not a generic quality tool adapted for medical device or aerospace.
Built for medical device
Designed specifically for ISO 13485 and FDA QMSR/21 CFR Part 820 or AS9100D and ISO 9001 compliance. Not a generic quality tool adapted for medical device or aerospace.
Configured for you
We configure Regulix 360 eQMS to your specific processes, workflows, and compliance requirements. You get a system that works for your company, not a generic out of the box tool.
Backed by regulatory expertise
Unlike off the shelf eQMS tools, Regulix 360 eQMS is backed by our regulatory consulting team. We know what auditors look for because we have been on both sides of the audit table.
Request a demo.
Complete the form and we will be in touch within one business day to schedule a walkthrough of Regulix eQMS and discuss how it fits your compliance needs.