ISO 13485 Certified Medical Mechatronics Innovation – From Concept to Serial Production

Mediagnost drives innovation for high-tech medical brands, offering expert mechatronics design, manufacturing, and testing—all under one roof. With over 30 years of proven heritage in the medical imaging and technology sectors, we help leading global medical equipment manufacturers reduce development risks and accelerate time-to-market. Every process is executed in strict compliance with our ISO 13485 certified quality management system.

Mechatronics Design
We develop complex system solutions based on detailed customer specifications and concept designs. Our PTC Creo design environment incorporates DFX (Design for Excellence) methods and state-of-the-art FEM engineering calculations to ensure cost-effective, premium design. To minimize compliance risks, our design process strictly adheres to a V-model framework compliant with IEC 60601 and FDA requirements, alongside maintaining full Device Master Records (DMR) and Device History Files (DHF) in PTC Windchill.

Industrialization & Prototyping
At Mediagnost, we bridge the gap between design and production. We provide comprehensive prototyping and concept verification to optimize designs for manufacturability. Our team aligns engineering requirements with mass production realities, managing pre-production phases to guarantee a seamless transition to full-scale, cost-effective serial production.

Manufacturing & Component Production

We possess extensive in-house manufacturing capabilities tailored to high-precision and complex medical requirements. Our advanced technological portfolio includes:

• 5-axis turning and milling for complex geometries

• Fine sheet metal working (cutting, bending, punching)

• Precision gear milling and automated welding

• Specialized safe lead processing

• Solvent-based painting and surface treatments

Integration & Testing
Complete modules—consisting of various mechanical, mechatronic components, technical cables, and electronics—are seamlessly integrated by our specialists. All assembly processes are performed based on strictly controlled operational instructions and supported by custom-designed functional test equipment, tools, and jigs. Full traceability is a fundamental standard: we track every single manufacturing data record from raw material receipt through to the finished medical product.

We aim to establish long-term strategic relationships with global MedTech OEMs, medical diagnostic brands, innovative medical device startups, and medical equipment manufacturers.We look for partners who require a highly reliable, certified European partner for external R&D, customized mechatronic subassembly design (such as X-ray collimators or table bases), high-precision prototyping, or complex contract manufacturing services.