Product development and mechanical design for medical technology
Classification
Medical technology carries a responsibility toward patients and users. A product must perform safely, predictably, and reliably in everyday clinical or mobile settings.
Trust is not built through a wide range of features, but through predictable behavior under real-world conditions.
Our contribution
We develop medical devices for regulated and safety-critical applications. Our starting point is either a medical use case (wireless endomotor), a therapeutic concept (respiratory therapy device), or a clearly defined need.
Together with our clients, we develop and validate ideas, concepts, and technical approaches. We either use existing solutions or build on them.
Our focus is on:
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Reliable and predictable device behavior
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Taking real-world clinical workflows into account
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Design for manufacturing and handover to production
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Early incorporation of regulatory requirements into the development process
Our role in the approval process
Our focus is on mechanical design and product development.
Approval of the finished product remains the responsibility of our clients.
However, we actively support them throughout the approval process by maintaining comprehensive documentation of all key design and development decisions, providing relevant data (e.g., on FDA-approved and physiologically safe materials), and implementing systematic risk management.
Design FMEA, Design for Manufacturing (DfM), and Design for Assembly (DfA) are integral parts of our work process.
Our quality management system is certified to ISO 9001.
How we support the registration process:
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Documentation of key design and development decisions
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Provision of relevant data (e.g., regarding FDA approval or the physiological compatibility of materials)
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Risk management using design FMEA
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Design methodology based on DfM / DfA
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Quality management according to ISO 9001 (ISO 13485 in the planning stages)
Result
The result is safe and reliable medical devices that can be used with confidence in everyday clinical practice and are sustainable in the long term, both technically and from a regulatory standpoint.
We apply similarly high standards of safety and stability in the development of complex laboratory and analytical instruments.
