Complaint Handling
Control intake, triage, investigation, escalation, risk/CAPA interfaces and closure.
€89Introductory single-organisation licence
Request availability 
Regulatory Knowledge & AdvisoryContact EUEG OÜProfessional regulatory documentation tools
Move from regulatory complexity to controlled, traceable work.
Fifty connected kits for medical-device quality, product evidence, clinical evaluation and EU regulatory readiness—developed as editable working tools by EUEG OÜ.
Templates support qualified work; they do not constitute legal advice, certification or regulatory approval.
Recommended starting points
Begin with a defined operational need.
Three practical entry points spanning post-market quality, clinical evaluation and technical documentation.
Clinical Evaluation Report Preparation and Review
Provide CER structure, source mapping, evaluator controls and maintenance records.
€149Introductory single-organisation licence
Request availability GSPR Applicability, Compliance and Evidence Matrix
Control Annex I applicability, conformity methods, evidence locations and gaps.
€149Introductory single-organisation licence
Request availability Complete portfolio
Eight families. Fifty specialist kits.
Search by task, evidence type or product code. Secure purchase links will be added after Lemon Squeezy onboarding and checkout testing.
QMS
QMS Foundation
Build the controlled foundation for a practical medical-device quality system.
CRV-QMS-01€89
Quality Manual and QMS Architecture
Define QMS scope, document hierarchy, process interaction, roles and an implementation roadmap.
EnquireCRV-QMS-02€79
Document and Record Control
Control document creation, review, change, distribution, retention and external sources.
EnquireCRV-QMS-03€79
Training and Competence Management
Structure training needs, competence assessment, authorization and effectiveness checks.
EnquireCRV-QMS-04€69
Management Review
Organize review inputs, evidence, minutes, decisions, actions and follow-up.
EnquireCRV-QMS-05€69
Quality Objectives and KPI
Turn priorities and process risks into measurable objectives and controlled indicators.
EnquireQOP
Core Quality Operations
Run quality events, corrective action, audits, changes and supplier controls consistently.
CRV-QOP-06€79
Nonconformity and Deviation Management
Control intake, containment, investigation, impact assessment, disposition and closure.
EnquireCRV-QOP-07€89
CAPA and Root Cause Analysis
Manage CAPA initiation, evidence-led root cause work, actions and effectiveness verification.
EnquireCRV-QOP-08€89
Change Control
Assess and control product, process, supplier, software, equipment and regulatory changes.
EnquireCRV-QOP-09€89
Internal Audit
Plan and document risk-based audits, findings, reports and closure.
EnquireCRV-QOP-10€99
Supplier Qualification and Purchasing Controls
Control supplier criticality, qualification, agreements, monitoring and re-evaluation.
EnquireDEV
Design and Development
Connect user needs, design controls, traceability, review, V&V and transfer.
CRV-DEV-11€109
Design and Development Control
Establish lifecycle governance, planning, stage gates, configuration control and design history.
EnquireCRV-DEV-12€89
User Needs and Design Inputs
Convert intended use, user needs, requirements and risks into reviewable inputs.
EnquireCRV-DEV-13€99
Design Outputs and Traceability
Structure outputs, acceptance criteria, baselines and bidirectional traceability.
EnquireCRV-DEV-14€79
Design Review
Control review readiness, reviewer competence, minutes, decisions and actions.
EnquireCRV-DEV-15€109
Verification and Validation Planning
Plan V&V coverage, methods, criteria, samples, facilities and deviations.
EnquireCRV-DEV-16€89
Design Transfer
Control production readiness, pilot evidence, configuration reconciliation and release.
EnquirePRD
Product Realisation
Plan and control manufacturing, validation, equipment, packaging and sterile-product evidence.
CRV-PRD-17€99
Manufacturing and Production Control
Structure specifications, work controls, acceptance, traceability and production evidence.
EnquireCRV-PRD-18€109
Process Validation
Control validation need, protocols, execution evidence, deviations and continued verification.
EnquireCRV-PRD-19€89
Equipment Qualification and Maintenance
Manage equipment requirements, qualification, maintenance, status and lifecycle review.
EnquireCRV-PRD-20€89
Calibration and Measurement Control
Control measurement suitability, calibration, traceability and out-of-tolerance impact.
EnquireCRV-PRD-21€119
Packaging Validation
Structure packaging requirements, validation evidence and ongoing control.
EnquireCRV-PRD-22€129
Sterilization Management
Organize sterilization strategy, supplier controls, validation and routine monitoring.
EnquireCRV-PRD-23€119
Shelf-Life and Transport Validation
Control stability, transport profiles, distribution evidence and claim boundaries.
EnquireSAF
Safety and Product Evidence
Create disciplined evidence structures for biological, usability, electrical, software and cyber work.
CRV-SAF-24€129
Biological Evaluation and Biocompatibility
Structure biological-risk planning, material/contact assessment and evidence gaps.
EnquireCRV-SAF-25€119
Usability Engineering
Control use specification, UI risks, formative work and usability validation evidence.
EnquireCRV-SAF-26€119
Electrical Safety and EMC Planning
Plan standards, configurations, testing, deviations and evidence readiness.
EnquireCRV-SAF-27€149
Software Lifecycle Documentation
Structure software planning, requirements, architecture, traceability, release and maintenance.
EnquireCRV-SAF-28€149
Cybersecurity Documentation
Organize threat assessment, security requirements, testing and vulnerability handling.
EnquireCRV-SAF-29€99
Verification Test Protocol and Report
Use controlled protocol, execution, result, deviation and reporting templates.
EnquireCRV-SAF-30€79
Standards and Common Specifications Register
Control applicability, editions, transitions, evidence mapping and monitoring.
EnquirePMS
Post-Market Quality Operations
Connect complaints, vigilance, corrective action, trends, PSUR and PMS reporting.
CRV-PMS-31€89
Complaint Handling
Control intake, triage, investigation, escalation, risk/CAPA interfaces and closure.
EnquireCRV-PMS-32€119
Vigilance and Serious Incident Reporting
Structure reportability assessment, timelines, authority reports and investigation.
EnquireCRV-PMS-33€129
Field Safety Corrective Action
Control FSCA decisions, affected scope, notices, execution and effectiveness.
EnquireCRV-PMS-34€99
Trend Reporting
Organize data definitions, thresholds, signal assessment and reporting decisions.
EnquireCRV-PMS-35€129
Periodic Safety Update Report
Structure data cuts, reconciliation, analysis, benefit-risk review and approval.
EnquireCRV-PMS-36€129
PMS Plan and Report Integration
Connect PMS planning, source data, findings, risk, clinical and quality actions.
EnquireCLN
Clinical Evidence and Evaluation
Build traceable clinical-evidence workflows from planning through CER and PMCF.
CRV-CLN-37€119
Clinical Evaluation Planning
Structure device scope, clinical questions, evidence strategy, gaps and governance.
EnquireCRV-CLN-38€109
Literature Search Planning and Protocol
Document databases, concepts, search strings, eligibility and update controls.
EnquireCRV-CLN-39€109
Literature Screening, Selection and Study Inventory
Control imports, deduplication, screening, exclusions, conflicts and evidence inventory.
EnquireCRV-CLN-40€129
Clinical Literature Appraisal and Evidence Weighting
Structure methodological quality, relevance, bias, weighting and reconciliation.
EnquireCRV-CLN-41€119
Clinical Evidence Extraction and Findings Matrix
Capture traceable device, population, performance and safety findings.
EnquireCRV-CLN-42€139
Clinical Evidence Analysis and Synthesis
Organize comparability, performance, benefit, safety, uncertainty and gap analysis.
EnquireCRV-CLN-43€149
Clinical Evaluation Report Preparation and Review
Provide CER structure, source mapping, evaluator controls and maintenance records.
EnquireCRV-CLN-44€149
PMCF Planning and Evaluation
Control PMCF need, strategy, plan, data quality and clinical integration.
EnquireCRV-CLN-45€169
Clinical Investigation Planning and Oversight
Structure feasibility, protocols, sites, conduct, safety, data and closeout.
EnquireREG
Technical Documentation and Regulatory Readiness
Prepare technical files, GSPR evidence, classification, labels, UDI and market release.
CRV-REG-46€139
Technical Documentation Structure and Submission Readiness
Build an Annex II/III dossier structure, evidence index, gap assessment and manifest.
EnquireCRV-REG-47€149
GSPR Applicability, Compliance and Evidence Matrix
Control Annex I applicability, conformity methods, evidence locations and gaps.
EnquireCRV-REG-48€149
Qualification, Classification and Conformity Route
Document MDR scope, borderline issues, classification and conformity route.
EnquireCRV-REG-49€149
Labelling, UDI and EUDAMED Registration Readiness
Align labels, IFUs, symbols, languages, identifiers and registration data.
EnquireCRV-REG-50€149
EU Declaration, CE Marking and Market Release
Control the declaration, CE-mark configuration, legal gates and release handover.
EnquireHow every kit works
Understand. Adapt. Review. Control.
Each kit guides disciplined work while preserving the purchaser’s responsibility for applicability, completion and approval.
Editable deliverablesWord templates, forms, checklists, registers, examples and Excel workbooks.
Visible controlsVersion, reference date, source-currentness prompts and defined review responsibilities.
Professional-use boundaryNo invented evidence, signatures, approvals, test results or device-specific conclusions.
Built by EUEG OÜ
Regulatory knowledge made operational.
Cervion is an EUEG OÜ product line for organizations that need practical, controlled structures for medical-device regulatory and quality work. Specialist advisory, customization and implementation support are scoped separately.
- Clear intended use and limitations
- Fictional examples separated from working templates
- Connected workflows across the product lifecycle
Commercial pathway
Cervion website + Lemon Squeezy
This website is the authoritative catalogue. Lemon Squeezy will provide secure checkout, tax handling and digital delivery. Whop will be used selectively for lead generation and market visibility.
Before checkout opens
Ask about availability, licensing or bundles.
Tell us which kit or family you are considering and whether you need templates only or separately scoped advisory support.
info@eueg.euProduct, licence and advisory enquiries