Capture quality events
Record nonconformities, supplier issues, audit findings, complaints, and improvement opportunities with consistent, searchable data.
Medical device quality
CAPA Software for FDA-Regulated Medical Device Teams
CAPA Manager helps medical device companies manage corrective and preventive actions as part of a controlled Quality Management System, with clear records, approvals, evidence, and traceability.
- ISO 13485Support controlled CAPA records, approvals, and effectiveness checks.
- FDA-awareDesigned to support 21 CFR Part 820 and Part 11 quality system expectations.
- TraceableKeep nonconformities, supplier issues, audit findings, and evidence connected.
Control investigation
Assign owners, gather evidence, investigate root cause, approve actions, and maintain a clear audit trail.
Verify closure
Use effectiveness checks, digital signatures, history, and exportable reports to keep CAPA records inspection-ready.
FDA CAPA software for medical device quality systems
CAPA Manager 3 is modern CAPA software designed to support FDA 21 CFR Part 820 and Part 11 quality system requirements. Medical device manufacturers can use CM3 to manage CAPA workflows for nonconformities, supplier issues, audit findings, complaint investigations, corrective action, preventive action, approvals, and secure traceability.
CM3 helps manufacturers maintain compliant, auditable CAPA processes for FDA-regulated industries by keeping records, responsibilities, evidence, approvals, and investigation history connected.
CAPA workflow control
Standardize initiation, investigation, action planning, approval, and closure across quality teams.
Electronic records
Keep centralized CAPA records, attachments, decisions, and history together.
Digital signatures
Use embedded digital signatures for secure approval tracking where required by your procedures.
Audit visibility
Maintain an auditable trail of changes, ownership, due dates, evidence, and effectiveness review.
ISO 13485 CAPA software for medical device quality systems
ISO 13485 teams need controlled records for nonconformities, complaints, supplier issues, investigations, corrective actions, approvals, and effectiveness checks. CAPA Manager helps medical device manufacturers keep those CAPA activities connected in one auditable workflow.
Use CAPA Manager to support ISO 13485 CAPA processes alongside FDA-regulated quality system expectations, while keeping the final responsibility for validation, procedures, and compliance with your organization.
- Controlled CAPA records and approval history
- Supplier issue and audit finding follow-up
- Root-cause analysis, action tracking, and effectiveness checks
- Clear reports for management review and audits
Start managing medical device CAPA records clearly
Easy to set up, simple to use, and designed for medical device manufacturers that want control and clarity.