Design Output Documentation
From Prototype to Production. Documented.
The 'Tribal Knowledge' Trap
The most dangerous risk in scaling from a working prototype to full-scale production is relying on knowledge that exists only in your lead engineer's head. This "tribal knowledge" is a liability that creates massive downstream costs.
Manufacturing Inconsistency
Production teams guessing at assembly steps because instructions are vague or incomplete, leading to high scrap rates and rework.
Supply Chain Blocks
Suppliers unable to quote or manufacture parts because critical specifications, tolerances, or CAD drawings are missing.
Audit Failures
Auditors issuing major findings because the final, released device doesn't match the documented specs in your DMR.
The Leanabl Insight
If it isn't documented, it doesn't exist. Professional design output documentation isn't "paperwork"—it is the physical embodiment of your intellectual property and the only way to ensure your device can be built consistently, cost-effectively, and compliantly at scale.
Audit-Ready Device Master Record (DMR)
We transform your final prototype into a complete technical package—the Device Master Record (DMR)—containing every specification, drawing, and procedure required to build, test, and maintain your device consistently.
Engineering Specifications & Drawings
Including 2D drawings with GD&T, 3D CAD files, material specs, and electrical schematics (PCBA).
Manufacturing & Assembly Instructions
Detailed Work Instructions (WIs), Standard Operating Procedures (SOPs), and identification of Critical-to-Quality (CTQ) parameters.
Labeling & Packaging Specs
Final label artwork, UDI specifications, Instructions for Use (IFU), and sterile barrier system specifications.
Bridging R&D and Operations
Gap Analysis & Audit
We audit your existing documentation against FDA and MDR standards to identify critical gaps before they become audit findings.
Documentation Engineering
Our team of engineers creates production-ready drawings, BOMs, and work instructions based on your final prototypes.
Design Transfer Package
We compile the complete Device Master Record (DMR) and manage the formal release process through your eQMS.
Your Complete Manufacturing Package
Complete Drawing Package
Production-ready PDFs and native CAD files.
Bill of Materials (BOM)
Structured, costed BOM ready for ERP import.
Device Master Record (DMR)
The complete, indexed set of documents.
Why Outsource Documentation?
DFM/DFA Expertise
We don't just document—we optimize. We flag non-manufacturable or hard-to-assemble features during the documentation process, saving you costly tool changes.
Regulatory-Ready Formatting
Our outputs are structured specifically for easy inclusion in 510(k), De Novo, and EU MDR/IVDR technical files, reducing submission prep time.
Lifecycle Management
We establish a robust Engineering Change Order (ECO) process, making it simple to manage revisions and maintain compliance post-launch.
Make Your Design Real.
Move from a "Science Project" to a "Scalable Product" with professional, audit-ready design output documentation.
Get Production-Ready