For startups and new product teams
Compliance documentation with the structure behind it.
Lumidocs delivers authored technical, clinical, software, and quality documentation while preserving the guidance, specifications, decisions, traceability, training, and workflows behind every section.
Delivery dashboard
Authored documentation set
37
documents affected
112
trace links
14
training items
Folders
Quality system
64 docs
Risk management
31 docs
Technical file
78 docs
Software file
42 docs
Training workflows
26 items
Risk management
31 docs
Risk management plan
Risk analysis report
Benefit-risk rationale
Traceability matrix
Use specification
PMS plan
Behind selected document
Guidance basis
MDCG · FDA · ISO/TR 24971
Obligations
MDR GSPR · ISO 14971
Specification
lay user training clarified
Decision
risk acceptability criteria approved
Specification updated
propagationBasic user training
Role-specific training
This change will propagate to 5 documents, 12 traceability links, 3 training items, and 2 workflow records.
Review surface
Every section carries its basis.
Before a document is accepted, your team can inspect the framework scope, guidance basis, source context, confirmed specifications, open confirmation points, and traceability behind the content.
Selected scope
The applicable standards, markets, device class, claims, and evidence context are visible.
Guidance basis
Relevant guidance and requirement interpretations are attached to the sections they inform.
Confirmed inputs
Specifications, applicability calls, and regulatory judgments are named for review and approval.
Traceable output
Document sections connect back to requirements, risks, evidence, training, and workflow implications.
Delivery journey
From scope to approved delivery.
The work moves through a defined path: select the applicable frameworks, resolve the missing inputs, approve the strategy, then assemble the documents, links, traceability, training, and workflows together.
01
Frameworks selected
The applicable standards and regulatory context are selected for the device, market, claims, and intended scope.
02
Guidance assessed
Relevant guidance and requirement interpretations are identified, assessed, and attached to the context they inform.
03
Missing specifications surfaced
Open product facts, scope choices, confirmations, and company decisions are named before authoring starts.
04
Strategy approved
The implementation strategy, specifications, and confirmation points are reviewed and approved.
05
Documents assembled together
Technical, clinical, quality, software, usability, and risk content are authored from the same source.
06
Links established
Cross-references, definitions, abbreviations, and shared facts are connected across the delivery.
07
Traceability populated
Decisions and specifications trace into requirements, risk controls, evidence, and document sections.
08
Training and workflows set up
Procedures, records, training obligations, and workflow implications are surfaced with the documentation.
Bring what exists
Start from your actual context.
A website, partial technical file, old procedures, scattered spreadsheets, supplier records, prior submissions, or an existing QMS. Lumidocs ingests what you have, reconciles it, and turns it into structured material the delivery can build from.
Structured source
Inspectable reasoning
Every substantive section links back to the requirement, guidance, source data, specification, or approved decision that produced it.
Formalized decisions
Regulatory judgments, implementation choices, applicability calls, and company confirmations become named decisions the company can keep using.
Clear confirmation points
Lumidocs surfaces the decisions only your team can make, while assembling the documentation, consistency, traceability, and structure around them.
What you receive
Mix and match the standards your device actually needs.
These are common examples. Scope one documentation set, combine a full startup stack, or add the specific standards required by your device, market, claims, and evidence strategy. Lumidocs can support most medical device frameworks and assemble the mix around your product context.
ISO 13485 documentation set
Authored QMS documentation for your operating context: procedures, records, roles, workflows, and implementation-ready quality files.
ISO 14971 risk management file
Risk plan, analysis, evaluation, controls, benefit-risk rationale, residual risk documentation, and linked design-control traceability.
IEC 62304 software file
Software plans, architecture, requirements, SOUP, risk-linked controls, verification structure, release records, and maintenance documentation.
IEC 62366-1 usability file
Use specification, user interface characteristics, use-related risk analysis, formative and summative structure, and usability engineering file.
Never repeat yourself
Write the fact once. Surface it everywhere.
Device descriptions, intended use, classifications, standards, definitions, risk controls, design inputs, tests, roles, references, and training obligations are registered as structured data.
Structured facts
Surfaced into
Technical file
Risk mgmt file
QMS record
Training
Assembled together
Every artifact is built from the same approved decisions.
Manuals, matrices, reports, records, applicability decisions, and cross-references assemble in synchrony. Consistency is a consequence of building from shared structured inputs.
Institutional memory
The decisions that shaped the delivery remain named, inspectable, and reusable after the files are exported.
Delivery validation
You receive the documents, the structure, and the validation record.
Lumidocs delivers the assembled documentation, the source structure behind it, and the validation performed after assembly. Any layer can be inspected: requirements, decisions, specifications, artifacts, traceability, guidance basis, open confirmations, and consistency checks. Changes can propagate upstream to the source decision or downstream into affected documents, records, training, and matrices.
Delivery layers
Documents, structure, validation
Documents assembled
authored files, templates, matrices, and records
Source structure preserved
requirements, decisions, specifications, and artifacts
Validation record attached
coverage, guidance basis, traceability, and consistency
Propagation paths available
changes can move upstream or downstream for review
Inspectable change paths
Upstream
change a specification or decision
Downstream
update affected documents and records
Governance
pending points remain visible
Clean exported documents
The exported files are clean, while the supporting structure retains the basis, validation, open items, and future change paths.
Indicative pricing
Fixed-scope authored documentation with source structure behind it.
Each delivery is scoped before work starts. If context is missing, a specification needs confirmation, or a company decision is required, Lumidocs surfaces the exact point to resolve in the delivery structure.
Single documentation set
from €2,000
One Lumidocs-authored standards-aligned package, scoped from your product context and delivered with explicit confirmation points.
Software device stack
often €8k-€12k
For teams combining ISO 13485, ISO 14971, IEC 62304, and IEC 62366-1, with traceability included across the set.
Custom standards mix
quoted upfront
Combine the standards and regulatory context your device actually needs. The examples show common starting points.
Traceability is included where the documentation requires it. For example, a risk management delivery can also establish and populate the relevant design-control traceability matrix from the same structured source.
Fixed scope
Start with the documentation set you need now. Keep the structure when you are ready.
Receive PDF or Markdown deliverables for immediate use, or continue maintaining the same source of truth inside Lumidocs as your quality system grows.
Scope a delivery