exploring new horizons
Jointly with our partners, we create future-oriented and innovative medical devices.
From the idea to the finished product.
Customized support for start-ups and innovative medtech companies
throughout the entire development process.
Project start phase
You have an idea for a new product or you need help to optimize your product and you are looking for competent support in its implementation. Our team helps you to detect the opportunities and risks of a technical implementation and how to use them positively. Crucial for this is a structured analysis of the project to obtain all the necessary information and requirements at an early stage so that a project can be successfully implemented. To give the project the best possible start, we create:
Project planning (time, milestones & budget)
Requirements engineering (user & stakeholder requirements, technical standards)
Risk management plan
Product development is one of our most important core competences. Thanks to our many years of experience in the development of medical products and an extensive national and international network of competent partner companies, we quickly and reliably can provide innovative solutions for a new product. Our development process follows the strictly guided specifications of a quality management system according to ISO 13485. Within the scope of technical development, we offer:
Development of electronic hardware and software
Risk management (e.g. risk analysis, dFMEA)
Test bench development
Functional testing, Proof-of-Concept
Design Freeze Evaluation
Product developments are always accompanied by the development and implementation of the corresponding manufacturing processes. In doing so, we also check the application of new innovative production technologies taking qualitative and economic factors into consideration. The subsequent testing and confirmation of process reliability is an essential part of our service.
Transfer of product development into series production
Development and implementation of innovative manufacturing processes
Implementation of quality assurance (test plan development & supplier qualification)
Risk analysis and pFMEAs
Design, construction and qualification of manufacturing tools, operating and handling equipment
Process capability analysis using statistical methods
Planning and implementation of process validations
(IQ / OQ / PQ)
Verification & Validation
Before the new product is approved and can used, it must undergo extensive verification that the product meets all requirements. Careful planning of these verification tests is crucial for efficient use of time and resources so that the product can be approved safely and quickly. Jointly with our partners, we offer a wide range of verification tasks:
Verification Master Plan
Design and construction of individual test benches
Conduct design verification tests: functional tests, stability, durability and usability, etc.
Preclinical studies (in vivo tests)
Manufacture, commissioning and qualification of test stands and test equipment
Validation of processes and systems
Jointly with our strong national and international partner network, we have been successfully developing medical devices at the technology location of Aachen for more than 20 years.
An agile and multidisciplinary team forms the basis for supporting our clients as a highly dynamic and flexible organisation.
Being strongly solution-oriented and transparent, we can also quickly fulfill individual customer requests through flat and efficient communication structures.