Service Provider
ACMIT offers R&D services along the complete chain of actions – with an integrative view.
Clinical workflow
Medical/surgical procedure performed by the clinical team
The development process
Our research activities address the complete course of actions in the operating room before, during, and after a minimally invasive intervention, such as:
Tools for (preoperative) image-guided planning of an intervention
Multi-functional tools
Robotic systems for accurate tool positioning
Optimized tool-tissue interaction
Sensor systems for intra- or post-operative monitoring
Intuitive interfaces and usability concepts
Workflow optimization and training of staff
Technology Integration
Our Expertise
Robotics
Mechatronics
Automation technology
Mechanical design
Applied materials technology
Polymer chemistry
Micro-optics
Fiber optics
Diffractive optics
Image processing
Our broad range of competencies enables us to cover R&D services along the entire development process. Our interdisciplinary team of experts is ready to offer you their skills.
Your Contact Person
Bernhard Nußbaumer
Dipl.-Ing. MAS EMBA
Managing Director & Co-Owner
+43 664 3582028bernhard.nussbaumer@acmit.at
From Idea to Medical Product
From the initial idea to the clinical application of a medical technology product, many development steps are to take and obstacles to overcome. ACMIT is your EN ISO-13485 certified partner during the complete innovation process and offers expertise, guidance and assistance in every single step.
We Perform
Technology research
State of the art analysis
Feasibility studies
Conception
System design
Prototype development
Industrial compatibility adaptation
System integration
Usability engineering and testing (formative and summative)
Validation under clinical conditions, i.e. in clinical trials
Low-volume production
Engineering Domains
Electronics
Optics / Photonics
Software
Mechanics
Usability Engineering
Concept Phase
Stakeholder Requirements
Product Requirements
Design Specification
Design & Verification
Design Transfer
Product Verification
Validation & Release
Fast and Reliable IOL Development with Visual Outcome Evaluation
Our optics team has been working in the field of intraocular implants since 2009, mainly in the evaluation and development of innovative intraocular lens designs.
Our experts use modern field tracing software to perform rigorous calculations of the electromagnetic field allowing in-depth analyses of even complex optical surfaces. Combined with conventional ray tracing software and more than 15 years of experience in IOL design, we provide optimized solutions for every IOL type: Â
Refractive and diffractive optics of any shape
Monofocal, monofocal plus, EDOF, bi- and multifocal surfaces
Toric, aspheric, sector shaped and freeform surfaces
We manufacture these highly complex optical surfaces in high precision to validate our theoretical designs and to evaluate the visual outcomes.Â
Besides our state-of-the-art equipment for optical testing, we use the optical system RALV (Real Artificial Lens Vision ©DEZIMAL GmbH) for lens evaluation. We have been working on the optical system of this device over a decade, and we are happy that this led to the spin-off company DEZIMAL GmbH. This device allows us to experience the visual performance of IOL prototypes in a real environment, which is an important step in the design process. Moreover, with this tool we are able to show our customers how their patients will see with a new IOL design.Â
With RALV, clinical studies can be carried out quickly, efficiently, and with manageable effort. Beyond predicting visual outcomes, the system enables a broader assessment of IOL performance, going beyond standard visual acuity testing. Its fast and simple lens exchange allows direct comparison of prototypes with competitor lenses already available on the market. Our team provides end-to-end study support, including study planning and management, subject recruitment, medical writing, data processing, and statistical analysis.Â
Once the optimal design has been selected, we support the seamless transfer into production. Our team adapts the optical design to your manufacturing equipment and established production workflows, helping to ensure a smooth transition from prototype to market-ready product. We provide technical guidance throughout the entire process, right up to market launch.Â
Would you like to learn more about our IOL development and visual outcome evaluation services? Please contact us at kirsten.lux@acmit.at.Â
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Engineering and Testing
Our all-in usability package includes all usability engineering tasks from start of product development to the complete usability file according to IEC 62366 - ready to submit for declaration of conformity.
Intended Use & Use Specification
User & Use Environment Analysis
Use Error & Hazard Analysis
User Interface Specification
UI Design & Implementation
Formative Evaluation
Summative Evaluation
Complete Usability File
Technical documentation review
Review of existing documentation, including intended use and risk management.
User research
Analysis of users, tasks and use environments through established research methods.
Use error risk analysis
Identification of hazard-related use scenarios and potential user errors.
Conceptual user interface design
Development of intuitive user interfaces according to usability standards and guidelines.
Formative usability testing
Early-stage evaluation through expert reviews, walkthroughs and verification activities.
Summative usability testing
Validation with representative users, either on-site or in ACMIT's usability lab.
Small Series of Medical Devices
EN ISO 13485-certified contract manufacturing
Small-volume production of medical devices
Optional clean room manufacturing
Supply chain management included
Open-book philosophy
Transparent and collaborative manufacturing process
Application-Oriented Models
We offer application-oriented anatomical models to significantly reduce the number of cadaver tests needed in the development of medical devices as well as to provide an advanced solution for education of clinicians. In addition, based on patient-specific manufactured models complex surgeries can be trained and optimized in order to improve patient safety. The big benefit of our application-oriented anatomical models is, that they are optimized regarding parameters, which are crucial for the clinical outcome.
For more information about our current application-oriented anatomical models´portfolio please visit our online shop or contact us by email webshop@acmit.at.Â
QM-System Starter Package
ACMIT Gmbh offers companies, in particular start-ups a quality management system (QMS) as a starter package.
The QMS starter package currently includes about 30 sample standard operating procedures (SOP) and about 100 sample templates in MS Word and MS Excel format. These samples will help you to create procedures and templates specific to your organization. The detailed procedures and templates can be found in the document "Scope Starter Package".
Our experienced quality management staff will be happy to assist you with establishing and maintaining your quality management system to meet all necessary regulatory requirements of EN ISO 13485:2021Â and Medical Devices Regulation (EU) 2017/745.
