Every engagement begins with the same question: where are the relationships unmanaged? Every engagement ends with the same standard: coherent records that can demonstrate themselves.
The LDLC framework is not a consulting methodology imposed on organizations. It is a diagnostic and architectural tool that reveals where relationships are unmanaged and provides a governance structure for managing them.
Every service listed below is an application of that framework to a specific domain of medical device quality and regulatory work.
User needs, design inputs, design outputs, risks, verification, validation, and transfer must remain synchronized throughout the product lifecycle — not just at gate reviews. LDLC applies governance architecture to the entire design control chain, ensuring that every relationship between URS, TDR, design inputs, risk controls, and verification evidence is explicit, maintained, and traceable.
Applicable to new product development, design changes, and design control remediation. Works within ISO 13485, 21 CFR Part 820 / QMSR, and EU MDR Technical Documentation requirements.
The Risk Management File is not a standalone document. It is a governed information structure that must maintain coherence with design inputs, design outputs, verification evidence, and post-market surveillance data. LDLC applies configuration management principles to the RMF, ensuring that every hazard, risk control, and residual risk record is explicitly connected to the requirements and evidence that govern it.
ISO 14971:2019 architecture. Hazard analysis governance. Risk control traceability to V&V evidence. PMS-to-RMF feedback loops.
Most organizations understand that these four record types exist. Few organizations have defined the governed relationships between them. LDLC applies an architectural discipline to the design-to-production record chain, clarifying the distinction between the design history (DHF), the current design baseline (MDF), the production specification (DMR), and the production evidence (DHR) — and governing the relationships between all four.
Applicable to organizations preparing for regulatory submission, undergoing design transfer, or remediating documentation systems following audit findings.
EU MDR Technical Documentation is not a compilation — it is a governed evidence package that must demonstrate coherence across biological safety, clinical evaluation, risk management, performance testing, and post-market surveillance. LDLC applies the same governance architecture to Technical Documentation structure and maintenance, ensuring that Section 6 (biological safety) maintains coherence with the RMF, that Section 9 (PMS plan) receives PMS feedback, and that the Technical Documentation as a whole can be demonstrated on demand.
Inspection readiness is not the possession of records. It is the ability to demonstrate coherent, traceable relationships between records — on demand, without reconstruction. LDLC engagements for inspection readiness begin with a coherence assessment: given a set of regulated outputs (design files, risk files, validation packages, technical documentation), can the organization trace every significant claim to its supporting evidence?
Preparation for FDA inspections, ISO 13485 surveillance audits, EU MDR Notified Body audits, and ANVISA regulatory inspections.
Validation records — IQ, OQ, PQ, software validation, process validation — are governed information units in the LDLC framework. They derive from requirements, they produce evidence, they govern production, and they require re-execution when their governing requirements change. LDLC applies governed relationship architecture to validation planning, execution, and maintenance, eliminating the most common validation failure mode: the undocumented assumption that a prior validation still applies.
Supplier quality records — audit reports, qualification records, incoming inspection procedures, supplier corrective actions — are governed objects in the LDLC framework. Account 700021 (material supplier) governs Part 900118 (polymer resin) which governs Specification 100519 which governs SOP 100524. When any element of that chain changes, the change impact must be assessed. LDLC applies configuration governance to the supplier-to-device chain.
Quality management system remediation is the application of the LDLC framework to a system that has been found non-conforming — whether by regulatory inspection, third-party audit, or internal assessment. LDLC approaches remediation architecturally: before revising documents, understand the governance failures that allowed them to become non-conforming. Before adding controls, understand what relationships are missing.
Representative work includes Quality Plan 100059 and Quality Manual 100060 remediation following inspection findings.
Configuration is the last thing on anyone's mind during an ERP or eQMS implementation — and the first thing that causes post-implementation failures. Taking poor paper habits and automating them creates automated failures at scale. Lean Configuration applies to system configuration: the structure of document types, the definition of relationships, the governance rules built into the system, and the validation of those configurations.
System-agnostic. Applicable to all major eQMS platforms and ERP systems with quality modules.
Not every organization is ready for a full LDLC implementation engagement. Discovery and gap assessment engagements begin with a structured diagnostic: which relationships are governed? Which are assumed? Where is the documentation system creating invisible risk? The output is an actionable architecture map, not a list of findings.
Typical duration: two to four weeks, depending on scope. Output: governance gap analysis, relationship architecture diagram, prioritized remediation roadmap.
Understand the current state: which records exist, which relationships are governed, which are assumed, where coherence breaks down under scrutiny. Output: governance gap map.
Define the governed relationship architecture for the engagement scope. Which records derive from which. Which changes trigger which assessments. Which work units govern which outputs.
Apply the architecture to the actual documents, information units, and work units of the organization. Build the governed system. Not the idealized one — the real one.
Demonstrate that the records now describe the same reality coherently. The test is not document review. The test is: can the system explain itself under inspection conditions?
The most valuable first step is understanding where the relationships in your system are unmanaged.