The technical documentation is the backbone of the approval of your medical device and must meet the strictest requirements of the MDR/IVDR. Compliance with the complexity of risk management (ISO 14971), numerous other regulations and the need for complete traceability ties up enormous resources. The manual maintenance and updating of content or regulatory changes across numerous documents is extremely time-consuming. The adaptation of technical documentation is a real cost driver and can become a decisive disadvantage in competition.
Imagine you need to make a change to the technical documentation at short notice. How many documents would you have to search through and adapt manually? How do you ensure that no information is forgotten, that all versions remain consistent and that this redundant work does not cost you valuable time?
BAYOOSOFT Themis has been specially developed to eliminate this manual burden. We offer you a validated and standards-compliant software solution that digitizes and connects your technical documentation processes and turns them into a true single source of truth. Benefit from a structured, process-led way of working that empowers your teams to meet regulatory requirements with maximum efficiency and quality, optimizing time-to-market.
From manual load to seamless safety: how we guide you to TecDoc excellence
Technical documentation according to MDR/IVDR is complex, time-consuming and error-prone – especially when information is distributed across dozens of documents. We will show you how to systematically solve these challenges with BAYOOSOFT Themis.
Thanks to the single source of truth, information in BAYOOSOFT Themis only needs to be maintained once in the system. The software automatically ensures consistency across all documents by intelligently linking the data once it has been entered. The system generates the complete, consistent documents – such as the technical documentation or the declaration of conformity – at the touch of a button, thus eliminating the manual workload.
The MDR and IVDR requirements and supplementary standards are complex and can quickly become confusing. Simply filing static documents is not enough to ensure that every single aspect of the regulations has been fully and correctly addressed. There is a lack of clear, structured guidance to ensure that no compliance point is forgotten.
Special MDR and IVDR-compliant instructions and interactive questionnaires provide a complete overview of all the necessary components of your TecDoc. They serve as an intelligent checklist that guides the user safely and process-guided through the regulations. This ensures that your documentation meets all legal requirements.
Complex processes such as risk management (ISO 14971) are often confusing without clear process management. The traceability of complex relationships – from the function to the risks to the measures – is quickly lost in static tables or individual documents. In particular, the balance between the necessary versioning (for audits) and continuous maintenance as a “living document” (for PMS) can hardly be guaranteed manually.
Specific, process-oriented application areas guide you through every step of these complex disciplines. You not only create a risk file, but also navigate through functions, risks and measures in a visualized structure. The system resolves the conflict between “living document” and versioning by keeping the elements continuously maintainable, but can freeze auditable snapshots (versions) at any time. This makes editing work intuitive and efficient, as all elements are seamlessly linked from the outset and traceability is automatically ensured.
Audits are a stress factor, as collecting all the evidence often means hours or days of manual search work. Even the smallest inconsistencies, missing versions or unlinked documents resulting from manual maintenance can lead to non-conformities and delays in approval. The effort involved is a real time waster.
With the audit trail on each element and structured navigation through all requirements, you have a complete overview at all times. You can quickly and easily present auditors with all the information they need from your single source of truth. The result: significantly faster creation of audit-compliant technical documentation and reduced risk during approvals and inspections.
How technical documentation works with BAYOOSOFT Themis: The task-based approach
BAYOOSOFT Themis breaks down the complexity of technical documentation into logical, manageable units. This task-based approach maximizes consistency and traceability by dividing your work into these four linkable levels:
The work unit for seamless consistency
The smallest, editable and self-contained task within a document, e.g. the intended use, a specific hazard or a risk measure.
Each task runs through a controlled workflow, can be assigned to unique people, commented on and, above all, linked to other tasks. Thanks to a unique ID, you can find every detail immediately and the audit trail seamlessly records every change.
The regulatory unit for versioning
Self-contained documentation blocks that fulfill a specific regulatory requirement (e.g. the risk management plan, the GSPR checklist or the MDR TD Guide).
Each document can be versioned and released individually. The system supports the idea of the “living document” by enabling continuous maintenance, but freezing versions that can be audited at any time for release, thus guaranteeing consistency and traceability.
The snapshot for audits
Defines development stages or checkpoints for your entire technical documentation.
You can freeze a traceable status of all your documentation at any time. This is ideal for the archive and essential for making changes and the current status transparent to auditors.
The superordinate control level
The highest unit for your documentation, typically a product or product family. Provides central control for all associated documents and tasks. This allows you to keep track of the progress of the entire product.
Deepen knowledge & test solution
You have seen how the task-based approach of BAYOOSOFT Themis reduces complexity and maximizes consistency. Find out now how this systematic security can help you in your audit, or get started with the solution right away.
Your BAYOOSOFT Themis modules for technical documentation
Every medical device is different – your documentation should be too. With the Themis modules, you can put together your own individual system: from the MDR and IVDR-compliant basis to specialized packages for risk management, requirements or device validation. Choose only what you really need.
Are you ready for the next step?
Make a non-binding appointment now for a free initial consultation, take your time to find out about the benefits of the Access Manager – or simply let us advise you.
