CRV-QMS-01€19
Quality Manual and QMS Architecture
Define QMS scope, document hierarchy, process interaction, roles and an implementation roadmap.
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QMS
QMS Foundation
Build the controlled foundation for a practical medical-device quality system.
CRV-QMS-02€19
Document and Record Control
Control document creation, review, change, distribution, retention and external sources.
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Training and Competence Management
Structure training needs, competence assessment, authorization and effectiveness checks.
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Management Review
Organize review inputs, evidence, minutes, decisions, actions and follow-up.
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Quality Objectives and KPI
Turn priorities and process risks into measurable objectives and controlled indicators.
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Core Quality Operations
Run quality events, corrective action, audits, changes and supplier controls consistently.
CRV-COQ-01€19
Nonconformity and Deviation Management
Control intake, containment, investigation, impact assessment, disposition and closure.
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CAPA and Root-Cause Analysis
Manage CAPA initiation, evidence-led root cause work, actions and effectiveness verification.
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Change Control
Assess and control product, process, supplier, software, equipment and regulatory changes.
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Internal Audit
Plan and document risk-based audits, findings, reports and closure.
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Supplier Qualification and Purchasing Controls
Control supplier criticality, qualification, agreements, monitoring and re-evaluation.
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Design and Development
Connect user needs, design controls, traceability, review, V&V and transfer.
CRV-DAD-01€29
Design and Development Control
Establish lifecycle governance, planning, stage gates, configuration control and design history.
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User Needs and Design Inputs
Convert intended use, user needs, requirements and risks into reviewable inputs.
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Design Outputs and Traceability
Structure outputs, acceptance criteria, baselines and bidirectional traceability.
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Design Review
Control review readiness, reviewer competence, minutes, decisions and actions.
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Verification and Validation Planning
Plan V&V coverage, methods, criteria, samples, facilities and deviations.
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Design Transfer
Control production readiness, pilot evidence, configuration reconciliation and release.
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Product Realisation
Plan and control manufacturing, validation, equipment, packaging and sterile-product evidence.
CRV-PRD-01€19
Manufacturing and Production Control
Structure specifications, work controls, acceptance, traceability and production evidence.
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Process Validation
Control validation need, protocols, execution evidence, deviations and continued verification.
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Equipment Qualification and Maintenance
Manage equipment requirements, qualification, maintenance, status and lifecycle review.
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Calibration and Measurement Control
Control measurement suitability, calibration, traceability and out-of-tolerance impact.
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Packaging Validation
Structure packaging requirements, validation evidence and ongoing control.
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Sterilization Management
Organize sterilization strategy, supplier controls, validation and routine monitoring.
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Shelf-Life and Transport Validation
Control stability, transport profiles, distribution evidence and claim boundaries.
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Safety and Product Evidence
Create disciplined evidence structures for biological, usability, electrical, software and cyber work.
CRV-SPE-01€29
Biological Evaluation and Biocompatibility
Structure biological-risk planning, material/contact assessment and evidence gaps.
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Usability Engineering
Control use specification, UI risks, formative work and usability validation evidence.
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Electrical Safety and EMC Planning
Plan standards, configurations, testing, deviations and evidence readiness.
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Software Lifecycle Documentation
Structure software planning, requirements, architecture, traceability, release and maintenance.
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Cybersecurity Documentation
Organize threat assessment, security requirements, testing and vulnerability handling.
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Verification Test Protocol and Report
Use controlled protocol, execution, result, deviation and reporting templates.
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Standards and Common Specifications Register
Control applicability, editions, transitions, evidence mapping and monitoring.
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Post-Market Quality Operations
Connect complaints, vigilance, corrective action, trends, PSUR and PMS reporting.
CRV-PMQ-01€19
Complaint Handling
Control intake, triage, investigation, escalation, risk/CAPA interfaces and closure.
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Vigilance and Serious-Incident Reporting
Structure reportability assessment, timelines, authority reports and investigation.
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Field Safety Corrective Action
Control FSCA decisions, affected scope, notices, execution and effectiveness.
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Trend Reporting
Organize data definitions, thresholds, signal assessment and reporting decisions.
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Periodic Safety Update Report (PSUR)
Structure data cuts, reconciliation, analysis, benefit-risk review and approval.
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Post-Market Surveillance Plan and PMS Report Integration
Connect PMS planning, source data, findings, risk, clinical and quality actions.
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Clinical Evidence and Evaluation
Build traceable clinical-evidence workflows from planning through CER and PMCF.
CRV-CEE-01€19
Clinical Evaluation Planning
Structure device scope, clinical questions, evidence strategy, gaps and governance.
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Literature Search Planning and Protocol
Document databases, concepts, search strings, eligibility and update controls.
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Literature Screening Selection and Study Inventory
Control imports, deduplication, screening, exclusions, conflicts and evidence inventory.
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Clinical Literature Appraisal and Evidence Weighting
Structure methodological quality, relevance, bias, weighting and reconciliation.
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Clinical Evidence Extraction and Findings Matrix
Capture traceable device, population, performance and safety findings.
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Clinical Evidence Analysis and Synthesis
Organize comparability, performance, benefit, safety, uncertainty and gap analysis.
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Clinical Evaluation Report Preparation and Review
Provide CER structure, source mapping, evaluator controls and maintenance records.
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PMCF Planning and Evaluation
Control PMCF need, strategy, plan, data quality and clinical integration.
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Clinical Investigation Planning and Oversight
Structure feasibility, protocols, sites, conduct, safety, data and closeout.
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Technical Documentation and Regulatory Readiness
Prepare technical files, GSPR evidence, classification, labels, UDI and market release.
CRV-TDR-01€29
Technical Documentation Structure and Submission Readiness
Build an Annex II/III dossier structure, evidence index, gap assessment and manifest.
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GSPR Applicability Compliance and Evidence Matrix
Control Annex I applicability, conformity methods, evidence locations and gaps.
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Medical Device Qualification Classification and Conformity Assessment Route
Document MDR scope, borderline issues, classification and conformity route.
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Labelling UDI and EUDAMED Registration Readiness
Align labels, IFUs, symbols, languages, identifiers and registration data.
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EU Declaration of Conformity CE Marking and Market Release Readiness
Control the declaration, CE-mark configuration, legal gates and release handover.
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