Capture quality events
Record nonconformities, complaints, supplier issues, audit findings and other quality events using consistent, searchable records.
Medical device quality
Medical Device CAPA Software for Quality Teams
Manage medical device CAPA, nonconformities, complaints, supplier issues and investigations in one controlled system, with clear ownership, evidence, approvals and effectiveness checks.
Designed to support ISO 13485:2016 and FDA QMSR quality system processes.
Free CAPA Manager Software — 2 Users, No Time Limit, No Credit Card.
- ISO 13485Support controlled CAPA, investigation and effectiveness records.
- FDA QMSRSupport medical device quality system and record requirements.
- Full traceabilityKeep issues, decisions, actions, evidence and approvals connected.
Investigate and control
Assign responsibility, gather evidence, investigate root cause and manage corrective and preventive actions through approval.
Verify effectiveness
Confirm actions have been effective, approve closure and retain the complete history for audit and inspection.
Medical device CAPA software for FDA QMSR
CAPA Manager helps medical device manufacturers manage corrective and preventive action within a controlled quality management system. Record nonconformities, complaints and supplier issues, investigate root cause, assign actions, retain evidence and verify effectiveness before closure.
For organizations operating under FDA requirements, CAPA Manager can support quality system processes under the FDA Quality Management System Regulation (QMSR). The QMSR became effective on February 2, 2026, and incorporates ISO 13485:2016 by reference.
Controlled CAPA workflow
Manage initiation, investigation, root cause, action, effectiveness and closure consistently.
Complete electronic records
Keep CAPA records, evidence, attachments, decisions and history together.
Controlled approvals
Record approval decisions and electronic sign-off with clear accountability.
Inspection-ready history
See changes, owners, actions, dates, evidence and effectiveness review in one traceable record.
Electronic records and approvals
Maintain controlled electronic CAPA records, approval history and traceability. Digital signatures can support your organization's electronic approval processes where applicable.
CAPA Manager is not represented as inherently compliant with, or validated for, 21 CFR Part 11. Electronic-record and signature use should be supported by a documented gap assessment covering intended use, procedures, validation and applicable regulatory requirements.
- Connected records, attachments and decision history
- Accountable approval and electronic sign-off
- Traceable ownership, dates and changes
- Evidence retained with the CAPA record
ISO 13485:2016 CAPA software for medical device quality systems
ISO 13485:2016 places strong emphasis on controlled quality processes and documented records throughout the medical device lifecycle. CAPA Manager helps teams connect nonconformities, complaints, supplier issues, investigations, corrective actions, approvals and effectiveness checks in one controlled workflow.
Use CAPA Manager as part of your ISO 13485 quality management system while retaining responsibility for your organization's procedures, software validation, regulatory requirements and overall compliance.
- 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
One system for medical device quality issues
Connect complaints, nonconformities, supplier issues and audit findings without losing the device, lot, failure or investigation details behind each record.
Nonconformities
Record internal quality problems and initiate investigation.
Customer complaints
Capture complaints and connect them to investigation and CAPA where required.
Supplier issues
Manage supplier nonconformities and corrective actions.
Audit findings
Assign and verify actions arising from internal or external audits.
CAPA
Manage root cause, actions, evidence, effectiveness and closure.
Quality improvements
Capture improvement opportunities and support prevention of repeated problems.
Connect investigations with medical device quality priorities
Connect CAPA decisions with ISO 14971:2019 risk information
Use relevant risk information to help prioritize investigations and corrective actions, document decisions and focus attention on issues with the greatest potential impact. CAPA Manager does not replace the medical-device risk-management process, records or controls required by ISO 14971:2019.
Manage complaints consistently
Record complaints alongside nonconformities, supplier issues and other quality events, then initiate investigation and corrective action where required while retaining supporting evidence and history.
Control supplier corrective actions
Record supplier-related nonconformities, assign corrective actions, gather evidence and maintain visibility through investigation, verification and closure. Explore supplier corrective action software.
Verify that corrective actions worked
CAPA does not end when an action is completed. Schedule follow-up, record effectiveness evidence and confirm that corrective actions have addressed the problem before final closure.
- Plan follow-up and effectiveness review
- Retain objective evidence with the investigation
- Record the effectiveness decision and approval
- Keep ineffective actions visible for further work
Be ready when records are requested
Keep CAPA ownership, investigation evidence, corrective actions, approvals, effectiveness checks and history connected in one record, making it easier to retrieve and review information during audits, inspections and management review.
FDA began using its updated QMSR medical-device inspection process on February 2, 2026, replacing the previous QSIT approach.
Bring your medical device CAPA process under control
Move away from disconnected spreadsheets, email and shared folders. CAPA Manager gives your quality team one controlled place to investigate problems, manage actions, retain evidence and verify effectiveness.
Free CAPA Manager Software — 2 Users, No Time Limit, No Credit Card.