Skip to content

ISO 13485 Process Workflow Editor: Turn SOPs into Audit-Ready Workflows

Design, manage, and enforce compliant workflows that turn your SOPs into clear,
executable processes, built for ISO 13485 medical device environments and adaptable to ISO 9001.

When procedures are interpreted differently across teams, audits expose the gaps.

Schedule a Demo

Pre-Configured Processes for Medical Device Companies

qmsWrapper includes a ready-to-use set of processes aligned with ISO 13485, designed to reflect how regulated medical device organizations actually operate.

  • Core quality and support processes available out of the box
  • Tasks and forms assigned within each process to the appropriate role or specific person
  • Structured to support risk-based thinking and audit expectations

ISO 9001 process templates are also available for non-medical-device organizations.

Pre-configured ISO 13485 aligned medical device QMS processes including CAPA, Change Control, Non-Conformance, Audit, Supplier Management and Training workflows
qmsWrapper Process Workflow Editor showing a visual process flow with decision nodes for medical device QMS

Turn SOPs into Executable Workflows

Static procedures don’t ensure consistent execution. Workflows do.

With the Process Workflow Editor, SOPs are mapped into step-by-step digital workflows that guide users through the correct sequence of actions, every time.

  • Each process is defined as a structured set of tasks and forms
  • Easy for front-line users to follow without interpretation or guesswork
  • Built-in logic enforces the required order of execution

Procedures stop being documents and start driving action.

Workflow diagram showing how quality management processes evolve from a simple approval workflow to more advanced workflows with risk assessment, supplier review, training, and verification steps as an organization grows.

Create, Edit, and Adapt Processes as You Grow

You are not limited to predefined templates. Processes can be created, extended, or adjusted as your organization evolves.

  • Build workflows that reflect your internal structure and responsibilities
  • Assign tasks by role or individual where appropriate
  • Modify processes as regulations, products, or teams change

Your QMS stays aligned with reality, not frozen in time.

Consistent Execution with Built-In Traceability

When a process is updated, every new record automatically follows the latest approved version, without manual rework.

  • One update applies across all future executions
  • Clear visibility into who did what, when, and under which process
  • Reliable evidence of process adherence during audits and inspections

This reduces process drift and makes deviations easier to detect and explain.

Diagram showing an approved workflow connected to multiple records that automatically follow the same approved process version, providing traceability and audit evidence.

See How Your Procedures Are Actually Executed in Practice

Schedule a demo to see how the Process Workflow Editor helps medical device teams maintain consistency, control, and audit readiness, without adding operational complexity.

Schedule Your Personalized qmsWrapper Demo

See how a Medical Device QMS works in real regulatory scenarios.