How does a medical device configurator support FDA and ISO 13485 traceability?

Every configurable option is linked to a controlled part record, and each configured order produces a versioned, locked bill of materials with an audit trail of who selected what and when. This supports ISO 13485 design controls and FDA design history file requirements, so device variants remain traceable from quote through manufacturing without manual reconciliation.

Can the configurator distinguish sterile and non-sterile configurations?

Yes. Sterile versus non-sterile is a controlled attribute that drives packaging, labeling, shelf-life, and the validated sterilization method such as EO or gamma. The configurator prevents incompatible combinations, like pairing a non-sterile accessory with a sterile-barrier package, so only validated, releasable configurations can be ordered.

Does it handle accessories and kit configurations?

It does. Accessories, disposables, and procedure kits are configured against compatibility and regulatory rules, so only cleared and compatible components can be combined into a finished device or kit. Each accessory carries its own UDI and lot-control attributes, and the configured kit BOM rolls those up for downstream labeling and manufacturing systems.

Configure Medical Devices With Full Traceability

A medical device configurator lets manufacturers offer configurable device options, sterile and non-sterile variants, and accessory kits while preserving FDA and ISO 13485 traceability on every order. Sell variety without compromising design control, validated combinations, or your audit trail.

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Device Configurator

Specifications

Configuration

Sterility

Accessories

Region

Configuration Output

✓ ISO 13485 traceable

✓ UDI assigned

✓ Regulatory (FDA) flagged

✓ DHR complete

Model: MD-STK-S

$7,450

Configuration That Respects Regulation

Only validated, compliant combinations can be ordered

Configurable Options

Offer size, length, connector, power, and feature options against a controlled rules engine so customers only see cleared, compatible combinations.

FDA & ISO 13485 Traceability

Each configuration links to controlled part records and produces a versioned, locked BOM with a full audit trail supporting design history file requirements.

Sterile vs Non-Sterile

Sterility is a controlled attribute driving packaging, labeling, shelf-life, and validated sterilization method, with incompatible pairings blocked automatically.

Accessories & Kits

Build procedure kits from compatible, cleared accessories and disposables, each carrying its own UDI and lot-control attributes for downstream labeling.

UDI-Ready Output

Configured devices generate UDI-ready BOMs and labeling data, keeping unique device identification consistent from quote to shipment.

Controlled Change Management

Option rules are version-controlled, so when a part or clearance changes, every future configuration reflects the approved revision instantly.

Why Device Manufacturers Configure

Speed and compliance in the same workflow

Faster, Compliant Quotes

Sales can configure complex device variants without waiting on regulatory or engineering review of every combination.

No Off-Label Combinations

Compatibility and clearance rules block configurations that fall outside what is validated and cleared for sale.

Audit-Ready Records

Every configured order carries a complete, time-stamped trail, simplifying internal and external audits.

Clean Handoff to Manufacturing

Locked BOMs flow into ERP and MES systems without re-keying or interpretation.

Built for Regulated Manufacturing

Connect device configuration to quality and production systems

Device Categories

Surgical instruments & sets
Implants & orthopedics
Diagnostic & imaging equipment
Disposables & procedure kits
Capital equipment with options
Catheters & delivery systems

Connected Systems

ERP & MES
QMS & document control
PLM & design control
CPQ quoting
UDI & labeling systems
Lot & serial tracking

Output Documents

Versioned, locked BOM
Configuration audit trail
UDI & labeling data
Sterilization & packaging spec
Customer quote
Manufacturing work order

If you are new to the category, see what a product configurator is and what CPQ software does before evaluating for regulated devices.

Offer Device Variety Without Losing Control

See how Ignitionary keeps sterile, accessory, and option configurations compliant and fully traceable.

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