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Production Planning

A practical system for managing medical device production from vendor qualification through finished device release, designed for FDA QSR and ISO 13485 environments.

Designed to generate required records as part of normal work, not as a separate process.

System overview

Tenodon has developed a streamlined production management system that supports the full lifecycle of medical device manufacturing.

The system integrates purchasing, inventory, assembly, testing, and documentation into a single workflow, ensuring that all required records are created as part of normal operations.

Production workflow

Vendor qualification and supplier management
Bill of materials (BOM) creation and maintenance
Purchasing and receiving
Inventory tracking and material control
Assembly processes and work instructions
In-process testing and verification
Final device testing and release
Shipping and traceability

Compliance by design

The system is designed to support FDA QSR and ISO 13485 requirements as part of normal operation.

Automatic construction of Device Master Records (DMR)
Automatic generation of Device History Records (DHR)
Full traceability of components, processes, and test results
Integrated document control and revision management

Handling real-world production issues

Nonconforming material tracking and disposition
Shortage detection and notification
Controlled rework and corrective actions
Visibility into production status and bottlenecks

Designed for actual production environments, not idealized workflows.

Lean and usable

The system was designed to be usable by a small team, avoiding unnecessary complexity while still meeting regulatory requirements.

Simple workflows aligned with how production actually operates
Minimal overhead for data entry and record keeping
Clear visibility into production status
Maintainable without large administrative teams

How Tenodon can help

Designing production systems aligned with regulatory requirements
Building or extending software to support manufacturing workflows
Integrating production processes with quality system requirements
Simplifying existing systems that have become overly complex

Philosophy

Production systems should make it easier to build compliant devices — not add unnecessary layers of complexity.