Summary
- Profile Type
- Technology request
- POD Reference
- TRDE20260615011
- Term of Validity
- 28 July 2026 - 28 July 2027
- Company's Country
- Germany
- Type of partnership
- Research and development cooperation agreement
- Targeted Countries
- All countries
General information
- Short Summary
- A German publishing-technology SME has built a semantic anchoring system that holds thousands of references stable across editing, structural change and multi-format output. The system runs in production. The applicant now seeks a MedTech partner to transfer the technology into MDR-regulated documentation under a ZIM cooperation. The partner contributes regulated use cases, validation under ISO 13485 conditions and access to a Notified Body audit perspective.
- Full Description
-
The applicant is a German SME operating in structured content production and multi-format publishing. Over the last four years the company has developed a semantic anchoring system that gives every relevant text element in an editable office-format document a persistent identifier. References stay attached to their content when documents are restructured, edited under change tracking or export-ed to several output channels in parallel. Per document the system handles between 3,000 and 9,000 anchored references. The system has been in productive use in the company's own editorial domain since late 2024.
The intended cooperation moves the technology into a different field: regulated technical documentation for medical devices under MDR 2017/745. References in that field are not editorial. A symbol, a warning, a product identifier or a clinical claim carries regulatory weight, and it has to stay consistent through the whole product life cycle, through up to 24 language versions, and through every audit a Notified Body decides to run. Tools used today in this market rely either on rigid component content management, on manual reference maintenance, or on layout workflows that lose semantic links somewhere between a translation round and a release approval. The company has seen no toolchain that solves this without trade-offs.
The project builds on the existing anchoring technology but requires substantial experimental development. Unresolved technical challenges concern the preservation of regulatory meaning across structural edits, multilingual transformations, terminology changes, redlining and controlled release processes. On top of this sit integration with translation memory and controlled terminology; audit trails that satisfy ISO 13485 change-control duties and MDR Annex II documentation requirements; mechanisms that carry the regulatory weight of a reference through translation, redlining and release; and validation methods that generate evidence suitable for review during quality-management and conformity-assessment audits. The cooperation delivers a demonstrator validated against real cases from the partner, plus an evaluation framework for regulatory fit.
The cooperation is designed for the German ZIM cooperative project track. Each side runs its own work packages and holds its own grant share. The company brings running technology, software-side R&D capacity and document-structure expertise. The partner brings the regulated domain and contributes its own regulatory-methodological R&D work packages — among them the development of a formal regulatory reference model, risk-based validation criteria, multilingual compliance rules, and methods for verifying reference integrity across document revisions, translations and release processes.
The parties intend to conclude a research and development cooperation agreement for the planned project. Rights to pre-existing technology, jointly developed results and subsequent exploitation will be regulated in a project-specific cooperation agreement. - Advantages and Innovations
-
The semantic anchoring base technology is in production in the applicant's own domain. For the MedTech application the work is at concept stage: the regulatory extension, the terminology integration and the audit-trail validation are the subject of the cooperation. A working demonstration of the base mechanism is available under NDA.
Innovative aspect: combining an operational semantic anchoring layer with regulatory binding logic, multilingual terminology control and audit-ready change history. The combination, as far as the applicant can see, is not available in current MedTech documentation tools. The cooperation tests whether it reduces reference maintenance effort and audit preparation time against measurable baselines from the partner's current practice. - Technical Specification or Expertise Sought
-
Sought is a partner with operational responsibility for MDR-regulated documentation. The partner brings the regulated domain the applicant does not have in-house.
Required:
• active responsibility for medical device documentation under MDR 2017/745 (instructions for use, technical documentation, labelling, clinical content);
• working knowledge of ISO 13485 quality management, in particular document and change control;
• practical experience with multilingual release, translation memory and controlled terminology;
• practical experience with audits and conformity-assessment procedures involving Notified Bodies (an institutional link to a Notified Body is not required);
• own R&D capacity to define regulatory acceptance criteria, co-develop the regulatory reference model and validation methodology, and run its own work packages;
• ability to name concrete validation scenarios, document structures and bottlenecks from current practice;
• willingness to provide realistic sample content (anonymised where required) for demonstrator validation;
• readiness to enter a formal cooperation under the German ZIM cooperative project track.
The semantic anchoring base technology is in production in the applicant's own domain. For the MedTech application the work is at concept stage: the regulatory extension, the terminology integration and the audit-trail validation are the subject of the cooperation. A working demonstration of the base mechanism is available under NDA. - Stage of Development
- Available for demonstration
- Sustainable Development Goals
- Goal 17: Partnerships to achieve the Goal
- IPR status
- Secret know-how
Partner Sought
- Expected Role of a Partner
-
The ideal partner is a medical-device manufacturer or a specialised regulatory-documentation provider working under MDR 2017/745 with an ISO 13485 quality management system and its own development resources. Small and medium-sized enterprises are prioritised; larger companies may remain eligible but are not the main target group.
Expected role of the partner within the cooperation:
• running its own R&D work packages, including a formal regulatory reference model, risk-based validation criteria, multilingual compliance rules and methods for verifying reference integrity across revisions, translations and release processes;
• providing a real regulated documentation case as the basis for the demonstrator (instructions for use, technical-documentation segment, multilingual label set or comparable);
• defining the regulatory acceptance criteria the demonstrator has to meet;
• operational testing under realistic editing, translation, review and release conditions;
• validation of audit-readiness against ISO 13485 and MDR documentation duties;
• joint authoring of the regulatory evaluation framework.
The partner is not a subcontractor and not a customer. It is a cooperation partner with its own work packages and its own grant share under the German ZIM cooperative project framework (or a comparable R&D funding route). The cooperation is bilateral and non-exclusive. Results are co-owned along a project-specific exploitation agreement.
The parties intend to conclude a research and development cooperation agreement for the planned project. Rights to pre-existing technology, jointly developed results and subsequent exploitation will be regulated in a project-specific cooperation agreement. - Type and Size of Partner
- SME 11-49
- SME <=10
- Big company
- SME 50 - 249
- Type of partnership
- Research and development cooperation agreement
Dissemination
- Technology keywords
- 01004010 - Quality Management System
- 01004001 - Applications for Health
- 06005003 - Health information management
- Market keywords
- 02007012 - Medical/health software
- 05007005 - Hospital and other institutional management
- 05007006 - Computer-aided diagnosis and therapy
- 02007027 - Other software services
- 05007007 - Other medical/health related (not elsewhere classified)
- Sector Groups Involved
- Health
- Targeted countries
- All countries