Capture, investigate, and resolve cases with validated workflows. MedQdoc Case Management centralizes Change Management, CAPA, nonconformities, complaints, and more with full traceability, SLAs, and audit-ready records for ISO 13485 and MDR.

Case Management Overview

Manage the full lifecycle of quality cases — log, assess risk, investigate root cause, implement actions, and verify effectiveness. Link every case to documents, procedures, and training for complete traceability.

Standardized case types: CAPA, Nonconformity, Complaint, Change Control
Risk assessment, root cause analysis, and action plans
Due dates, owners, and reminders to keep cases on track

Explore how MedQdoc streamlines Case Management and accelerates compliance.

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CASE Structure in MedQdoc

The CASE Structure in MedQdoc provides a standardized and traceable way to manage quality events and business processes.

Each Case is based on a predefined template that defines its content, flow, and lifecycle — ensuring every action follows a validated, compliant process.

Standardized Framework

Each Case template defines the content and structure of the process, typically including five or more Case Steps that guide the workflow from initiation to closure. This framework ensures every case follows the same compliant, auditable approach across all process types.

MedQdoc Case Management Process overview

Case Step Content

The main section of each Case Step contains configurable fields such as dropdown menus, yes/no options, text fields, product references, and links to related documents or other Cases. This allows consistent data entry and ensures full documentation of every decision and action.

Each step has a descriptive name such as Information, Risk Management, Action Plan, Review, or Closure. Steps define the purpose of the activity and align with the QMS workflow for traceability and compliance.

Case Step Completion

Each step can be saved as a draft or marked as complete to move forward in the workflow. Once a step is completed, the case automatically transitions to the next defined status — maintaining structure and control. Some steps may also include a review and approval phase.

Lifecycle Workflow

All Cases follow a defined lifecycle workflow with five different statuses that represent progress from initiation to closure.

These lifecycle statuses ensure traceability, accountability, and visibility throughout the process.

The following stages are part of the MedQdoc Case Status Lifecycle:

Registered
In Progress
Resolved
Closed
Archived

Configuration and Flexibility

Each Case template includes predefined rules and configurations that determine how and when a Case changes status. MedQdoc administrators can tailor workflows to organizational needs while maintaining compliance with ISO 13485, QSR, MDR, and/or IVDR.

MedQdoc Case Management Status Lifecycle diagram

Every step is fully documented and audit-ready — giving your MedTech organization complete control and confidence in every Case process.

Explore more …

Explore predefined Case Management workflows below. MedQdoc includes a set of ready-to-use templates designed to support common quality processes.

With PRO+ Custom, your organization can also design company-specific case workflows — fully tailored to your internal procedures.

Change Management

Control planned changes to products, processes, and documents with full traceability and approval workflows. MedQdoc ensures that every change is assessed, reviewed, and approved before implementation — keeping your QMS compliant and audit-ready.

Manage product, process, and document changes in one controlled system
Perform impact assessments across risks, SOPs, and training
Use multi-step electronic approvals compliant with 21 CFR Part 11
Track implementation progress and verify completion

Customer Complaints

Capture, assess, and manage customer complaints with full traceability and compliance. MedQdoc helps you document, investigate, and resolve complaints efficiently while meeting ISO 13485, MDR, and FDA requirements.

Register complaints and link them to related products or batches
Evaluate reportability and escalate to CAPA when needed
Track investigation steps, root cause, and corrective actions
Maintain a complete complaint history for audits and post-market surveillance

Nonconformities

Record and manage nonconformities to ensure quick containment, correction, and long-term prevention. MedQdoc provides structured workflows to capture deviations, assign actions, and link to CAPA or change control when needed.

Register and classify nonconformities with defined categories and risk levels
Document containment, correction, and verification of effectiveness
Escalate recurring or critical issues to CAPA or change management
Track status, ownership, and timelines for full visibility and traceability

CAPA (Corrective and Preventive Actions)

Manage CAPA processes efficiently with structured workflows that guide you from issue identification to verified resolution. MedQdoc ensures every step is documented, traceable, and compliant with ISO 13485, MDR, and FDA QSR.

Initiate CAPA directly from nonconformities, complaints, or audits
Perform root cause analysis using methods like 5 Why or Fishbone
Plan, assign, and track corrective and preventive actions
Verify effectiveness and close CAPA with full audit traceability

Audit Trails

Maintain complete visibility and traceability for every case. MedQdoc automatically records all actions — from creation and updates to approvals and closures — ensuring compliance and inspection readiness.

Automatic logging of all user actions, timestamps, and changes
Full traceability from initial report to final verification
Secure, read-only audit trail compliant with 21 CFR Part 11
Printable records for audits, inspections, and management review

Supplier Management

Manage and monitor supplier performance, qualifications, and related quality activities directly in MedQdoc. Link suppliers to audits, nonconformities, and CAPA for full traceability and control throughout the supply chain.

Maintain an approved supplier list with qualification status and risk level
Record supplier evaluations, audits, and follow-up actions
Link suppliers to nonconformities, complaints, and CAPA cases
Track supplier performance and trends to support continuous improvement

Discover how MedQdoc simplifies supplier control and qualification.

Learn more about our features on the Supplier Management page for details and real examples.

Training Management

Manage employee training and competence directly in MedQdoc. Link training requirements to documents, roles, and change actions to ensure every team member is qualified and up to date with the latest procedures.

Assign and track training linked to SOPs, CAPA, or change control
Set due dates, reminders, and electronic sign-offs for completion
Maintain training records and certificates for audits and inspections
Generate competence reports to support ISO 13485 and MDR compliance

Discover how MedQdoc simplifies employee training and competence management. Learn more about our features on the Training Management page for details and real examples.

Link to Documents and Other Cases

Connect cases to related documents, templates, or other cases for full traceability and context. MedQdoc ensures all linked records stay synchronized and accessible within your QMS.

Link CAPA, complaints, and nonconformities to relevant SOPs or reports
Attach technical documentation, risk files, or change records
Cross-reference related cases to maintain a complete investigation history

Equipment Management

Keep track of all equipment used in production, testing, and calibration with full traceability. MedQdoc helps you plan maintenance, record calibration, and ensure every instrument remains compliant and audit-ready.

Register equipment with unique IDs, calibration intervals, and status
Plan and document calibration and preventive maintenance activities
Track usage, responsible person, and equipment location
Attach certificates, reports, and related records for audits and inspections

“I have had the pleasure of performing multiple internal audits on two different companies both using the eQMS MedQdoc. This system is well designed, user-friendly and facilitates not just document control but also effective case management. MedQdoc gives a good overview of the Quality Management System and provides users with the relevant documentation and information as and when required. I wholeheartedly recommend this well-designed system.” Melanie Janbro, Quality Consultant, Vinga Medtech Q Consulting