Ergo-Tec – Partner for Medical Device Development, Regulatory and Manufacturing

We support medical device companies across all critical steps from concept to market-ready product. Our work connects development, regulatory preparation, sourcing, and manufacturing – so that technical decisions, compliance requirements, and production processes align from the start.

Based on your needs, we take over complete projects or selected phases. This includes developing production-ready concepts, building and testing prototypes, preparing regulatory documentation, sourcing compliant components, and manufacturing devices in mid-volume series.

A key advantage is the reduction of interfaces and coordination effort. Instead of managing multiple partners, you work with one team that understands how development, approval, and production interact. This helps avoid delays, reduces iterations, and keeps projects moving.

We also support companies that need additional components or systems to complete their products. These are developed and integrated so that they fit technically, meet regulatory requirements, and can be manufactured efficiently and economically.

You define requirements and specifications – we implement them in a structured and transparent way. This allows you to stay flexible while keeping full control over your product. All results remain traceable, and your know-how stays protected.

With over 25 years of experience and certification according to DIN EN ISO 13485, we work with clearly defined processes across all project phases – enabling efficient execution and economically viable results.