Technical Consulting Straight from the Field
We know what to expect when implementing your ideas.
As a successful development service provider, our diverse projects and in-house products, as well as our focus on high-end medical devices, have provided us with a wealth of practical experience that enables our customers implement innovative projects more quickly.
Accelerate Market Access and Reduce Costs with Secure Product Development
With over 300 successfully completed MedTech projects, our R&D Consulting division offers customized and flexible strategies for a wide range of challenges. Our core team of safety experts has been working closely together for more than 10 years and specializes in the development and optimization of high-performance medical devices, including Class IIb and III. Thanks to our in-depth manufacturing knowledge, we support our customers in bringing reliable medical devices to market faster and efficiently designing their production processes.
Get Started With the Best Conditions
A clear vision and a thorough analysis are crucial for the start of a successful project. We help you to comply with all standards and technical requirements and to create the right development environment. From the specification sheet to the successful testing of your system, we guide your team through all challenges and help you to place your medical device safely and successfully on the market.
Requirements Engineering
System Footprint Workshops
When new developments only occur every 5-8 years, requirements engineering experience may be lacking, leading to misunderstandings and unclear specifications. Important matters often go undocumented because they are simply assumed.
We create a common vision for all stakeholders, document all specifications and functions to ensure a clear and testable requirements that identifies challenges early on and minimizes errors.
- Identify, record and jointly evaluate customer wishes and regulatory requirements
- Create and document technical, testable requirements at system level
- Ensure traceability of the requirements file (system & subsystem, risk-minimizing requirements, verification)
- Visualization of the system footprint with functions, components, interfaces and technical framework conditions
Software & Algorithm Reviews
Code Analysis & SW-Compiler Optimizing
Software errors and code inaccuracies rarely but severely compromise the critical functionality of medical devices, while inefficient algorithms further complicate maintenance. And strict regulatory requirements add to this complexity.
Our detailed code reviews, combined with AI-enhanced algorithms, resolve issues early, improving software performance and reliability, while ensuring product safety and approval.
- Software check for functionality, performance, security gaps and compliance with best practices in coding
- Static and dynamic code analysis
- Algorithm evaluation in terms of accuracy, efficiency and reliable results
- Software Compiler Optimization
- Review of regulations for medical devices (AI Act readiness)
System Testing
V&V Testing to Automated Testing
In medical technology, testing often focuses only on core functions, while edge cases and stress scenarios are neglected. Developers are often too close to the product to be objective testers, and manual testing is time-consuming, error-prone and increases the risk of recall.
Our System Testing provides external, independent testing that saves time and avoids costly rework. Automated processes also enhance the consistency and repeatability of testing, resulting in a safe, reliable product.
- Review of the requirements documents: Checking requirements for testability.
- Test case design for efficient test cases from the requirements.
- System tests, incl. vital and shock parameters, communication, usability and continuous loads.
- Verification & Validation Testing
- Test bench construction and validation of test environments with LabView and Robot Framework.
There Is No Such Thing as Complete Security – but We Are Working on It
We develop customized security solutions that can be integrated into every phase of product development to identify and eliminate vulnerabilities early. Through reviews and detailed concepts we ensure that all technical components work together optimally and are resistant to threats.
Cybersecurity concepts
- Risk assessment of threats
- Security architecture design
- Encryption and network segmentation
- Access restriction
- Cybersecurity Life Cycle (Updates & Patches)
- Pen Testing & Vulnerability Scans
Circuit design & layout
- High interference resistance for the highest functional requirements
- EMC-compliant circuit and layout design
- Functional safety requirements
- Redundancies
- Watchdog-Integration
- Voltage & current monitoring
Proof of Concept (HW & SW)
- Assessment of technical feasibility
- Definition of core functions and objectives
- Advice on selecting hardware and software components
- Minimal Viable Product (MVP) or prototypes
- Testing of MVP, subsystems and complete systems
System Architecture
- Managing technical responsibility for the entire system
- Creating specifications and distribute requirements to components
- Creation of the system architecture, interfaces and solution space
- Modularization and variant management
- Reviewing architectures and identifying blind spots
Success Stories
Let us help you to secure your development.
Dorothee Kitz
Business Development Manager
