What can meddevo do and what can’t it do?
What is meddevo?
meddevo is a specialized software solution for managing the technical documentation (TD) of medical devices. It organizes, automates, and exports data and documents in a structured, efficient, and regulatory-compliant manner — especially in the context of MDR/IVDR.
meddevo is not a system for comprehensive process mapping. It is primarily a central tool for document management. It does not support the complete creation, control, or mapping of entire processes (such as risk management, design development, clinical evaluation, CAPA, or complaint handling) — it manages and stores the documents and data those processes produce.
Capability Matrix
| Area | Capability | Supported | Notes |
|---|---|---|---|
| Document Management & Product Data | Structured management of all data and documents related to medical devices | ✅ | |
| Automatic generation and updating of documents based on stored data | ✅ | ||
| Versioning and approval of documents | ✅ | ||
| Document templates for reuse | ✅ | ||
| Management of clear folder structures | ✅ | ||
| Import and export of documents and product data | ✅ | ||
| Individual, free-form document design (like Microsoft Word) | ❌ | Fonts and layouts are deliberately limited to enable standardization and automation | |
| Change history within a document | ❌ | Change tracking exists as a separate meddevo module, accessible anytime via the software | |
| Product Requirements & Technical Documentation | Maintenance and management of product-specific requirements and product variants | ✅ | |
| Linking product data with relevant regulatory supporting documents | ✅ | ||
| Automated compilation and updating of the technical documentation | ✅ | ||
| Mapping the complete design and development process of a product | ❌ | Milestones, tasks, and project management are not tracked in meddevo | |
| Risk Management | Management and storage of risk management plans and reports as part of the TD | ✅ | |
| Performing risk analyses (e.g. FMEA matrices) | ❌ | No structured matrix functionality | |
| Automated calculation, action tracking, or matrix features for risks | ❌ | Risk scoring, mitigation action follow-up, and matrix visualizations are not available | |
| Tracking individual risks within a comprehensive risk management process | ❌ | meddevo stores the resulting plans/reports, offers no automatic tracking of single risks through their lifecycle | |
| Clinical Evaluation & Literature | Management of documents for clinical evaluation (CEP/CER) | ✅ | |
| Carrying out or supporting literature searches or appraisals | ❌ | No literature database, search, review, or appraisal tools included | |
| Structured management or automation of clinical evaluation processes | ❌ | The CEP/CER documents are stored and versioned, but the underlying step-by-step project management of the clinical evaluation itself is not run in meddevo | |
| Post-Market Surveillance (PMS) | Storing, managing, and versioning PMS-relevant documents (e.g. PMS Plan, PMS Report) | ✅ | As part of the technical documentation |
| Documenting and archiving additional evidence or reports generated during PMS | ✅ | ||
| Comprehensive PMS process mapping or management | ❌ | meddevo is not a dedicated PMS module; it does not represent the PMS process as a workflow | |
| Execution, monitoring, or control of PMS processes | ❌ | No database-driven monitoring, evaluation, or research functions | |
| Interfaces to external databases for automatic PMS data collection/analysis | ❌ | No automated pull of vigilance, complaint, or market data from external sources | |
| Quality Management (QM) & Training | Storage, versioning, and approval of QM-relevant documents | ✅ | |
| Recording and managing of TD-related QM-processes (Change Control, CAPA, Complaint Handling) | ✅ | ||
| Executing or controlling individual process steps (starting, handling tasks, changing status) | ❌ | No digital "execution" of process steps | |
| Automated support for training management, audit planning, or management reviews | ❌ | These QM activities need to be run and scheduled outside meddevo; only resulting documents can be stored | |
| Management or control of employee training / qualification tracking | ❌ | No training records, certificates, or qualification status are tracked in meddevo | |
| Visualization or modeling of processes (e.g. flowcharts, workflow diagrams) | ❌ | meddevo has no process-modeling or flowchart functionality |
Summary
meddevo is the right tool for managing and automating documents and product-related data around medical devices. Complete processes — such as risk analyses, design development, QM measures, and clinical evaluation — cannot be controlled, documented, or visualized as continuous workflows within meddevo. Functionality always refers to the management of the associated documents, not the execution of the process itself.
For process management, workflow control, or more in-depth functional areas, supplementary systems or manual procedures outside of meddevo are required.