Development, approval and ISO 13485-compliant production of medical technology – from components to complete systems
ai6 SOLUTIONS GmbH
Heilbronn (74076) · Production site (area code 09122)New on Amplifa
About ai6 Solutions
ai6 SOLUTIONS GmbH is a full-service provider for manufacturers in the medical technology sector, headquartered in Heilbronn. As a group of companies, it supports medical devices across the entire value chain: from the idea phase and product development (software, firmware, electronics, mechanics) through regulatory consulting and approval management (MDR, CE, FDA) to ISO 13485-compliant series production, assembly and testing of complex electromechanical devices. This is complemented by industrialization (Design to Cost, Design for Manufacturing), supply chain management, and lifecycle services such as returns analysis, repair and obsolescence management. Manufacturing covers prototypes, individual products and small to medium series on approximately 5,500 m² of production space. The group also develops special-purpose systems as well as manufacturing and testing equipment, and additionally serves the stage and event technology sector as well as in vitro diagnostics. With over 200 employees and more than 1,200 realized customer products, ai6 Solutions works internationally, including with clinics such as Johns Hopkins and university hospitals in Freiburg and Kiel.
- Site
- Heilbronn
- Processes
- Medical technology production (series production of medical devices, ISO 13485-compliant), Assembly of complex electromechanical systems, Testing and quality assurance (comprehensive in-house testing), Electronics production/programming, Special-purpose systems construction, Manufacture of manufacturing and testing equipment, Product development from idea to series-production readiness (software/firmware, systems, Prototype manufacturing (individual products and prototypes)
- Materials
- Software and firmware development, Electronics development and electronics production, Mechanics and engineering design, Assembly and testing, Prototype manufacturing, Special-purpose systems construction
- Certificates
- EN ISO 13485
- Employees
- 200+
- Industries
- Medical technology, In vitro diagnostics, Stage and event technology
- 01
Idea phase and concept
- 02
Development (software, firmware, electronics, mechanics)
- 03
Industrialization (Design to Cost, Design for Manufacturing)
- 04
Supply chain (sourcing, supplier qualification)
- 05
ISO 13485-compliant manufacturing
- 06
Assembly and testing
- 07
Approval management (MDR, CE, FDA)
- 08
Lifecycle management and after-sales
Processes and Competencies
Software and firmware development
Development of medical device software, including anesthesia monitoring software with a patient database.
Electronics development and electronics production
Electronic assemblies and functional modules, e.g. UWB distance measurement for medical devices.
Mechanics and engineering design
Design implementation and mechanical adaptation of devices such as ergonomic monitoring systems.
Assembly and testing
ISO 13485-compliant assembly of complex electromechanical systems including comprehensive in-house testing.
Prototype manufacturing
Production of individual products and prototypes up to series-production readiness.
Special-purpose systems construction
Design and construction of special-purpose systems as well as manufacturing and testing equipment.
Locations
Heilbronn
DECentral office / Headquarter
Production site (area code 09122)
DEProduction
- Lot size
- Prototypes to medium series
- Materials
- Medical technology components and systems
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Medical technology production (series production of medical devices, ISO 13485-compliant)Assembly | – | – | – | – | – |
| Assembly of complex electromechanical systemsAssembly | – | – | – | – | – |
| Testing and quality assurance (comprehensive in-house testing)Testing | – | – | – | – | – |
| Electronics production/programmingAssembly | – | – | – | – | – |
| Special-purpose systems constructionEngineering | – | – | – | – | – |
| Manufacture of manufacturing and testing equipmentEngineering | – | – | – | – | – |
| Product development from idea to series-production readiness (software/firmware, systemsEngineering | – | – | – | – | – |
| Prototype manufacturing (individual products and prototypes)Assembly | – | – | – | – | – |
| Regulatory consulting (approvals, technical documentation, QM systems)Engineering | – | – | – | – | – |
| Industrialization (Design to Cost, Design for Manufacturing/Quality/Supply Chain)Engineering | – | – | – | – | – |
| Lifecycle services (returns analyses, repair services, obsolescence management,Assembly | – | – | – | – | – |
1 Anlagen & Maschinen
| Machine | Manufacturer / model | Quantity | Working area | Year built | Site |
|---|---|---|---|---|---|
| Production space | – | – | 5,500 m² (entire group; website counter also shows 5,000+ m²) | – | Heilbronn / group locations |
Additional services
Reference customers
Quality
ai6 Solutions is certified to EN ISO 13485 and implements national and international quality standards in development and production. Comprehensive testing is carried out in-house, complemented by transparent processes and reliable partners in external approval and certification processes.
| Evidence | Heilbronn |
|---|---|
| EN ISO 13485 |
History
- 2007
Hisnija Schilling joins ai6 Solutions GmbH (HR department)
- 2017
Roman Gruler joins ai6 Solutions GmbH; Head of Business Unit Engineering since 2020
- 2022
Introduction of the current logo (aesco-solutions-logo-2022)