Frameworks
From ISO 13485 to MDR, Lumidocs turns frameworks into structured execution.
Select the standards and regulatory contexts your device needs. Lumidocs translates them into requirements, decisions, specifications, artifacts, traceability, and checks, then assembles the documentation from that structure.
Common device profiles
Start from the device, then select the framework mix.
Many teams do not begin with a standards list. They begin with a device, market, risk class, software scope, and evidence gap. Lumidocs turns that profile into the framework stack and delivery scope.
SaMD
Software lifecycle, risk, clinical evaluation, cybersecurity, post-market, and submission structure.
Connected devices
Cybersecurity, software, risk controls, labeling, PMS, vulnerability handling, and update workflows.
AI-enabled devices
Risk management, transparency, human oversight, data governance, validation, monitoring, and change strategy.
IVDs
IVDR technical documentation, performance evaluation, PMS/PMPF, labeling, risk, and QMS context.
Class IIa / IIb devices
MDR technical documentation, GSPR, clinical evaluation, PMS/PMCF, risk, usability, labeling, and QMS evidence.
Class III devices
Higher-risk documentation structure, clinical evidence, PMCF, PMS, risk-benefit, traceability, and regulatory strategy.
Guidance layer
Guidance is used across every framework.
Framework support is not limited to the standard text. Lumidocs uses FDA, MDCG, and IMDRF guidance where relevant, and separates binding requirements from sourced implementation practice.
FDA
Guidance and recognized consensus-standard context used where relevant to the device, market, and submission path.
MDCG
EU MDR / IVDR guidance used to support applicability, technical documentation, clinical, PMS, software, and cybersecurity decisions.
IMDRF
International guidance used for SaMD, clinical evaluation, UDI, cybersecurity, and regulatory best practice context.
Practitioner consensus
Best-practice research is marked as such and tied to sources, not presented as binding regulatory text.
Supported areas
Mix the frameworks your device actually needs.
These areas can be delivered as standalone documentation packages or combined into one structured source, so shared definitions, decisions, evidence, traceability, and applicability determinations stay aligned.
Quality systems
Quality system structure, procedures, records, management responsibilities, audits, CAPA, document control, and training.
Frameworks
Typical Lumidocs outputs
Connects to
Risk management · Design controls · Supplier controls · Post-market
Design controls
Design and development planning, inputs, outputs, review, verification, validation, transfer, changes, DHF structure, and traceability.
Frameworks
Typical Lumidocs outputs
Connects to
Risk management · Software · Usability · Clinical · Technical documentation
FDA market access
US regulatory strategy artifacts, design history structure, submission organization, software documentation, and post-market quality links.
Frameworks
Typical Lumidocs outputs
Connects to
Risk · Software · Clinical · Design controls · Post-market
Risk management
Risk management planning, hazard analysis, risk controls, benefit-risk rationale, residual risk, and production/post-production feedback.
Frameworks
Typical Lumidocs outputs
Connects to
Design inputs · Software controls · Usability · Clinical evidence
Software lifecycle
Software planning, safety classification, requirements, architecture, verification, SOUP, release, maintenance, and problem resolution.
Frameworks
Typical Lumidocs outputs
Connects to
Risk controls · Cybersecurity · Design history · Traceability
Cybersecurity
Security planning, risk controls, secure development, threat modeling, vulnerability handling, SBOM context, and maintenance evidence.
Frameworks
Typical Lumidocs outputs
Connects to
Software lifecycle · Risk management · Post-market surveillance · Labeling
Usability engineering
Use specification, user interface characteristics, use-related risk, formative evaluation, summative validation, and usability file structure.
Frameworks
Typical Lumidocs outputs
Connects to
Risk management · Clinical evaluation · Labeling · Design validation
Clinical evidence
Clinical evaluation planning, clinical investigation structure, PMCF context, evidence appraisal, and report structure.
Frameworks
Typical Lumidocs outputs
Connects to
Intended purpose · Claims · Risk-benefit · Post-market surveillance
Biological safety
Biological evaluation planning, endpoint rationale, material and contact characterization, gap structure, and evidence mapping.
Frameworks
Typical Lumidocs outputs
Connects to
Materials · Clinical evidence · Risk management · Technical file
Labeling and information supplied
Labeling requirements, symbols, IFU structure, warnings, device information, and consistency with claims and risk controls.
Frameworks
Typical Lumidocs outputs
Connects to
Risk controls · Usability · Claims · Technical documentation
EU technical documentation
GSPR mapping, technical documentation structure, applicability decisions, evidence coverage, PMS / PMCF context, and traceability.
Frameworks
Typical Lumidocs outputs
Connects to
QMS · Risk · Clinical · Labeling · Post-market
Sterile barrier and packaging
Packaging process documentation, validation planning, record structure, supplier context, and evidence traceability.
Frameworks
Typical Lumidocs outputs
Connects to
Supplier controls · Production records · Risk management · Technical documentation
Post-market and vigilance
PMS planning, PMCF linkage, complaint handling, vigilance triggers, trend reporting, feedback loops, and report structure.
Frameworks
Typical Lumidocs outputs
Connects to
CAPA · Risk updates · Clinical evidence · Regulatory reporting
What support means
Frameworks become structured execution, not generic templates.
The delivery method is described on the Compliance Deliverables page. The key point here is scope: Lumidocs supports the documentation, traceability, structure, and governance around these frameworks.
Requirements are structured into obligations, decisions, specifications, artifacts, and checks.
Frameworks can be mixed where the device needs them; examples are examples, not fixed bundles.
Test-center generated work is not positioned as a Lumidocs-generated deliverable.
When a framework requires external test evidence, Lumidocs can structure the documentation, traceability, and evidence mapping around that evidence.
Framework delivery
Start with one framework or combine the full stack.
Bring your product context, target markets, existing files, and standards scope. Lumidocs will turn the selected framework mix into a concrete, reviewable delivery scope.
Scope a framework delivery