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. The system focuses on organizing, automating, and exporting data and documents in a structured, efficient, and regulatory-compliant manner – especially in the context of MDR/IVDR.
Important:
meddevo is not a system for comprehensive process mapping. It is primarily designed as a central tool for your document management. meddevo does not support the complete creation, control, or mapping of entire processes (such as risk management, design development, clinical evaluation, CAPA, or complaint handling).
What can meddevo do and what can’t it do?
Organized by area:
Document Management & Product Data
meddevo can:
- Structured management of all data and documents related to your 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
meddevo cannot:
- meddevo does not provide individual document design like Microsoft Word. Available font types and layouts are deliberately limited to enable standardization and automation.
- meddevo does not support change history within a document. Change tracking is integrated into meddevo as a module and can be accessed at any time via the software.
Product Requirements & Technical Documentation
meddevo can:
- 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
meddevo cannot:
- meddevo does not map the complete design and development process of a product. Milestones, tasks, and project management are not managed or tracked in meddevo.
Risk Management
meddevo can:
- Management and storage of risk management plans and reports as part of the technical documentation
meddevo cannot:
- meddevo does not perform risk analyses (e.g. FMEA matrices) and does not offer the possibility to manage them in a structured matrix.
- meddevo does not support automated calculation, action tracking, or matrix features for risks.
- meddevo does not enable tracking of individual risks within a comprehensive risk management process.
Clinical Evaluation & Literature
meddevo can:
- Management of documents for clinical evaluation (CEP/CER)
meddevo cannot:
- meddevo does not provide functions for carrying out or supporting literature searches or appraisals. A literature database, search, review, or appraisal tools are not included in the system.
- meddevo does not enable structured management or automation of clinical evaluation processes.
Post-Market Surveillance (PMS)
meddevo can:
- Store, manage, and version all PMS-relevant documents such as the PMS Plan and PMS Report as part of the technical documentation.
- Document and archive any additional evidence or reports generated during the PMS process.
meddevo cannot:
- meddevo is not a comprehensive PMS module and does not map or manage Post-Market Surveillance processes.
- meddevo does not provide functions for the execution, monitoring, or control of PMS processes. Database-driven management, ongoing monitoring, evaluations, or research functions required for comprehensive PMS management are not included in meddevo.
- meddevo does not offer interfaces to external databases for the automatic collection or analysis of PMS data.
Quality Management (QM) & Training
meddevo can:
- Storage, versioning, and approval of QM-relevant documents.
- Processes related to QM, such as Change Control, CAPA, or Complaint Handling, can be recorded and managed in meddevo.
meddevo cannot:
- meddevo does not map processes in the sense of actual execution or process control. This specifically means that executing, managing, or tracking individual process steps (e.g. starting, handling tasks, changing status) does not take place in meddevo and is not supported or guided by the software. There is no function in meddevo to digitally "execute" or complete a process step.
- meddevo does not provide automated support for QM processes such as training management, audit planning, or management reviews. Tracking of tasks and status management within a process is also not possible.
- meddevo does not provide any functions for the management or control of employee training. Tracking of training records or qualification verification does not take place in meddevo.
- meddevo does not enable visualization or modeling of processes, for example as flowcharts or workflow functions.
Summary
meddevo is the right tool for managing and automating documents and product-related data around your 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 only to the management of the respective associated documents.
For process management, workflow control, or more in-depth functional areas, you require supplementary systems or manual procedures outside of meddevo.