Manage medical device nonconformities with MedQdoc

Nonconformity Workflow in MedQdoc

The MedQdoc Nonconformity workflow helps medical device companies manage nonconformities through a structured, compliant, and fully traceable process. With predefined workflows for medtech, teams can document issues, assess impact, assign responsibilities, track actions, and move records from initiation to closure in a controlled way.

• Registration: Record the nonconformity and any immediate correction taken.
• Assessment: Evaluate the impact, severity, and need for escalation.
• Investigation: Document findings, identify root cause, and determine whether further action is required.
• Disposition: Decide how the affected product, material, or process should be handled.
• Action Plan & Follow-up: Assign responsibilities and track corrective actions through completion.
• Review & Closure: Complete final verification and approval.

Purpose-Driven Workflow Steps

Each step in the nonconformity workflow has a clear and specific purpose, such as information gathering, risk assessment, or action tracking. Steps can be saved as drafts or completed to move the record forward in a controlled way. As each stage is completed, the nonconformity progresses through the workflow with full traceability, helping teams maintain structure, accountability, and support regulatory compliance throughout the case lifecycle.

Key Benefits of MedQdoc

Managing nonconformities in MedQdoc helps quality teams work in a more structured, consistent, and audit-ready way.

• Supports a controlled and traceable nonconformity process from initiation to closure.
• Helps maintain audit readiness through structured documentation and defined workflow steps.
• Supports regulatory compliance with predefined workflows designed for medical device companies.
• Improves accountability through assigned responsibilities, review stages, and approval steps.
• Makes it easier for smaller medtech teams to manage nonconformities in a consistent way.

Regulatory Framework

Medical device companies need documented procedures for identifying, evaluating, and controlling nonconformities. MedQdoc supports this with predefined workflows for medtech that help teams manage nonconformities in a structured, traceable, and compliant way.

• ISO 13485:2016 — Clause 8.3
  Requires organizations to identify and control nonconforming product and maintain records of the nonconformity, related evaluations, and actions taken.
• 21 CFR Part 820 / FDA QMSR
  Requires manufacturers to establish documented procedures for the identification, evaluation, segregation, and disposition of nonconforming product, including appropriate review and approval.

Purpose of Nonconformity Management

The purpose of nonconformity management is to help medical device companies handle deviations in a structured, traceable, and compliant way. By ensuring that issues are identified, assessed, documented, and followed through to closure, teams can improve audit readiness, support regulatory compliance, and maintain better control across products, processes, and quality system activities.

Case Management Workflows in MedQdoc

Nonconformity Management is part of MedQdoc’s predefined Case Management workflows for medical device companies. These workflows help teams manage quality events in a structured, traceable, and compliant way.

• Change Management
• Nonconformity Management
• CAPA
• Customer Complaint
• Supplier Management
• Training Management
• Equipment Management

Organizations using PRO+ Custom can also adapt workflows to fit their internal QMS, responsibilities, and product scope.

Book a Demo

Want to see how MedQdoc can support your nonconformity process? Book a demo to explore predefined workflows for medical device companies and see how MedQdoc supports traceability, audit readiness, and regulatory compliance.

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