Lean Documents, Lean Configuration: A Smarter Path Through Medical Device Complexity

The Hidden Cost of Documentation Complexity

I once opened a design history file and saw 28 nearly identical work instructions, each differing only by a product reference number. The processes were the same, yet each had been written, reviewed, and approved as if it was a unique artifact. Sound familiar? 

This is the reality many teams face in the medical device industry: documentation that grows more complex with every iteration, not clearer. It slows down development, confuses reviewers, and risks non-compliance. Yet this complexity is often self-inflicted. We keep repeating the same patterns because “that’s the way it’s always been done”. 

What if the problem isn’t your team, but the structure itself? Lean Documents and Lean Configuration (LDLC) offer a better way. 

Regulatory Requirements for Medical Device Documentation

Under the FDA’s Quality Management System Regulation (QMSR), which updates and replaces much of 21 CFR Part 820, manufacturers are required to establish and maintain robust design and production controls aligned with ISO 13485. This includes maintaining objective evidence that design and development activities are planned, controlled, and verified throughout the product lifecycle. 

Records such as the Design History File (DHF), Device Master Record (DMR), and Device History Record (DHR) remain foundational mechanisms for demonstrating that a medical device was developed, manufactured, and controlled in accordance with approved requirements and established processes. 

But here’s the key: the FDA defines what must be done, not how it must be documented. That leaves room for flexibility and innovation in how we meet the requirements. 

Too often, documentation systems are built around bloated templates, copy-pasted PDFs, and redundant data. The result is over-documentation without added value. 

What Are Lean Documents and Lean Configuration?

Lean Documents are single-purpose, modular documents designed to do one job well. They don’t describe themselves with lengthy boilerplate (e.g., “Purpose” and “Scope” sections on page one), nor do they try to include every piece of related metadata. That metadata is stored upstream. 

Lean Configuration refers to the separation and management of reusable data elements, like models, serial numbers, and part specs, in a structured, traceable way. These elements can be assembled into complete, compliant configurations without duplicating their content in every document. 

This modular approach reduces: 

• Document sprawl 
• Conflicting versions 
• Time spent in reviews and audits 

It also increases: 

• Traceability across variants 
• Reusability across projects 
• Compliance clarity 

Instead of embedding everything into massive PDFs, you reference the appropriate configuration table. Instead of 28 nearly identical WIs, you have one work instruction plus a lean configuration that drives the variant-specific content. 

Why Traditional QMS Documentation Breaks Down

Most teams have encountered these: 

• PDFs that mix purpose, process, and config data into one bloated file.
• Obsolete documents that remain in circulation because no one owns their cleanup.
• Training fatigue due to repeated review of near-duplicate instructions.
• Audits derailed by inconsistencies between versions or systems.

These are structural problems. We’ve asked our systems to carry the entire cognitive burden of the organisation, and they buckle under the weight. 

Lean Documents and Lean Configuration offer an antidote: stop asking each document to be everything. Let it do one job and let configuration drive the rest. 

Case Study: Simplifying Work Instructions at Scale

At one company, engineers had created 28 separate work instructions to support 28 product variants. Each document had its own number, history, and approval cycle. When we introduced LDLC principles, we collapsed these into: 

• One master work instruction (lean document).
• One configuration table linking part numbers, tooling, and test methods.

Review cycles shortened. Training became simpler. Traceability improved. During a mock audit, the inspector said, “This is one of the cleanest configurations I’ve seen”. 

The biggest win? We didn’t just write better documents, we redesigned how information flows. 

How to Implement Lean Documentation in Medical Devices

You don’t need to overhaul everything. Start small: 

• Identify one document family with high redundancy (e.g., SOPs or DHF trackers).
• Separate the configuration data into a standalone, referenceable table. 
• Strip out boilerplate that doesn’t serve the document’s function.

You can also pilot the approach in risk management or design inputs – anywhere traceability and reuse are essential. 

The Business Case for Lean Medical Device Documentation

In an era of increasing regulatory scrutiny and global complexity, clarity is your competitive advantage. LDLC doesn’t cut corners; it cuts clutter. 

LDLC invites us to ask better questions: 

• Does this document serve a clear purpose? 
• Is this information reused elsewhere? 
• Can we decouple structure from content? 

Lean Documents and Lean Configuration are not workarounds. They are a smarter, leaner way to fulfil the exact same requirements with more focus, less waste, and greater control. 

Disclaimer. The views and opinions expressed in this article are solely those of the author and do not necessarily reflect the official policy or position of Test Labs Limited. The content provided is for informational purposes only and is not intended to constitute legal or professional advice. Test Labs assumes no responsibility for any errors or omissions in the content of this article, nor for any actions taken in reliance thereon.