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Medical Devices & Equipment

Manufacturing Software Built for When Life Is at Stake

FactoryLogix gives every device you build a complete, audit-ready history down to the component, carrying you from configure-to-order production through FDA and ISO compliance in one system.

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Trusted by Medical Device and Equipment Manufacturers Worldwide

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unigen
4front solutions
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kimball electronics
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Where Medical Device Production Breaks Down

Audit Prep Takes Over the Quarter

An audit means pulling approvals, signatures, and process records for specific units, sometimes going back years. Manufacturers selling into multiple regions face several regulatory regimes at once, and each one wants the evidence assembled its own way.

A Complaint Arrives and the Scope Is Unknown

When a field complaint or recall investigation opens, the only question that matters is which units are affected. If traceability stops at the lot, the answer is the whole lot, and product that was never at risk gets pulled.

Every Change Triggers Revalidation

New product, new line, new supplier, new software version. Each one carries a validation burden, and the work is usually the same documents rewritten by hand.

Personalized Products Break Standard Work

Patient-specific and configurable devices mean the build differs unit to unit. Work instructions, kitting, and inspection steps written for one standard product stop holding up, and the operator ends up deciding what correct looks like.

A Defect That Ships Is a Patient Risk

In most industries a quality escape is a cost problem. Here it becomes a patient outcome, a field action, and a regulatory event at the same time.

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A Second Site Doesn't Inherit the First One's Process

Standing up a plant in another region means rebuilding the validated process, often against a different regulator and in another language. Six months later the two sites are building the same product two different ways, and both have to hold up under audit.

Built to Carry the Compliance Burden For You

Compliance Evidence That Assembles Itself

Approvals, electronic signatures, and process steps are captured as production happens, so the record an auditor asks for already exists in the form they want it. Audit prep becomes a query instead of a project. 

Full Device History for Any Serial Number (eDHR)

Traceability runs forward and backward to the individual component, down to the pin on a circuit card and that component's manufacturer lot. When a complaint comes in, the affected population is a specific list of units, and everything else stays in the field. 

Cut Manual Data Entry, Not Corners

FactoryLogix is a GAMP Category 4 configurable system, and Aegis supplies its own test plans and QA documentation on request. Your validation team begins with the vendor evidence already assembled and validates configuration rather than code. e. 


One Process Definition, Every Configuration

 Product structure and work instructions carry the configuration, so a patient-specific or made-to-order device runs on the same released process as a standard one. Engineering releases the variant; the floor sees the right steps. 

Quality Caught at the Station

Nonconformance and CAPA workflows trigger where the defect occurs, with the unit, operator, and process context attached. Containment happens while the product is still in the building and the investigation starts with the evidence already gathered. 

Scale a Validated Process Without Starting Over

Simio's process simulation and Advanced Planning and Scheduling (APS), used standalone or together, model capacity and changeover sequencing for configure-to-order production, so a validated process scales to a new site or line without starting the plan from scratch.

Featured Resource

Traceability Medical Device Manufacturing

Discover how medical device manufacturers can move beyond manual, reactive traceability to capture complete production records as manufacturing happens. Learn how stronger traceability can simplify compliance, reduce risk, accelerate reporting, and improve recall response. 

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Featured Customer Story

9.4%

Initial Improvement in Overall First Pass Yield

90%

Reduction in Document Generation Time

enercon technologies

Other clients we've helped

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celestica
ikor
TT electronics
Daktronics
asteelflash

Solutions Built for Regulated, 
Zero-Defect Manufacturing

Regulatory & Customer Compliance

Automated 21 CFR Part 11, ISO, and GAMP5-ready reporting generated directly from production data.

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Quality Management System

Closed-loop CAPA and non-conformance workflows enforced at the point of occurrence.

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Digital Manufacturing Engineering

Author and govern configure-to-order work instructions directly from CAD and BOM data.

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Manufacturing Process Execution

Guide every operator to the correct process and revision, with full electronic sign-off.

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Simulation & Capacity Planning

Simio tests changeover sequencing and line capacity against your actual mix before you commit the schedule, so you know what a new product or volume increase does to throughput while there's still time to change the plan.

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Manufacturing Intelligence

Real-time dashboards standardize KPI and quality reporting across every site.

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FAQs

Yes. FactoryLogix meets FDA 21 CFR Part 11 with built-in electronic signatures on every approval and process step, and supports Part 820 quality system requirements through closed-loop CAPA and non-conformance workflows.

See FactoryLogix for Medical Device Manufacturing

Get a guided walkthrough of compliance automation, eDHR generation, and validation-ready architecture built for medical devices.

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