Successful medical devices begin with strong ideas and conceptualization. At Ergo-Tec, we support you from day one, turning your idea into a coherent, functional and realizable concept. Efficient, protocoled research and development based on your ideas and specifications begins the road to a market-ready product and serial production.
Engineering that works for you
Innovative product development
Your idea in prototype
Our development team gives shape to your idea through computer-aided design (CAD). Its results feed the prototyping phase to produce a physical, tangible model of your idea. This allows Ergo-Tec to test your product at the earliest stages by identifying opportunities for further optimization, gathering customer feedback, and conducting trials. The prototype thus serves as an aid for optimal decision-making and further development; a valuable investment that saves you time and money.
We test, you succeed: Approval-ready products
The safety and reliability of a medical device are crucial to its success. At Ergo-Tec, we rely on extensive in-house testing to ensure that your product is convincing and compliant in all respects, whether it be durability and handling or international regulations or standards. Our tests prepare your product for any external testing procedures that may be required.
Our in-house testing capabilities
Performance & Durability
- Weight load – Ensures stability and resilience of mechanical parts
- Stability – Validates long-term structural robustness, ensuring consistent performance over years of use
- Motion – Tests durability of movable components
- Safe Working Load – Defines the product’s maximum load limits for safe, trouble-free operation
Safety & Compliance
- User & Patient Safety – Validates safe and comfortable use
- Temperature & Environment – Verifies function under various climatic conditions
- Splash Water – Assesses resistance to moisture and splashes
- ADA Compliance – Checks accessibility under the Americans with Disabilities Act
Regulatory expertise – so you’re ready for approval
Quality & Certification
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Certified Processes – As a DIN EN ISO 13485–certified manufacturer, we meet the highest quality standards. This makes approval procedures smoother and faster for all devices we produce – including yours.
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Audit-Ready – We meet all relevant medical technology standards, making audits straightforward and freeing you to focus on your priorities and core business.
Global Market Access
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Full Documentation Service – We prepare all regulatory documentation and coordinate directly with testing labs and notified bodies – reliably and efficiently.
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Ready for International Markets – Together with our notified body, we support Class II approvals and can produce your devices for the US market.
Solutions tailored to your needs
We select. You save time.
We help you choose the right materials to ensure your medical device performs reliably, safely, and cost-effectively. By outsourcing the entire material and supplier search to us, you save valuable internal resources – and reduce costs, risks, and time to market.
We scan & print. You see results.
CAD technologies, including 3D scanning and printing, allow our team to quickly turn your product ideas into tangible prototypes. This eases internal and external testing and minimizes errors at an early stage and improves your medical device.
We vet. You profit.
We carefully select and vet all suppliers to ensure that product components meet our trusted quality requirements. You can rely on smooth production processes, concentrate on your core business, and expect on-time delivery.
