How can you fulfill all requirements, such as a traceable design process, comprehensive technical documentation, technical testing, biocompatibility, and more, while at the same time developing an outstanding product?
We coach your product from the initial idea to the series production stage through a modular system of services and offer you Technology consulting by experienced experts in product and process development.
We structure your development process according to internationally recognized models such as the Waterfall model, V-model, Agile, or SCRUM. All of these approaches can be easily aligned with the requirements of ISO 13485 and the EU MDR/IVDR regulations, providing an ideal framework for designing medical device development. .
Working closely with you, we choose the right development models and tools tailored to your organization and products, and set the corresponding processes and methods for design and development. Our aim is for the required development-related documentation (medical device file) and mandated traceability to grow seamlessly throughout the process.
Our offer:
- Project management: Systematic, controlled procedures and clear authorities enable a goal-oriented approach and help detect costly development errors at an early stage.
- Document control: Going forward, products and documents will be developed in parallel, ensuring minimal effort and maximum regulatory compliance.
- Requirements Engineering: We ensure traceability into development—from the various requirements all the way to product validation.
- Knowledge management: Experiences from previous developments become the basis for a continuous innovation process.
Interested in support for your development project?
We are happy to help!
*) Traceability = traceability
