Medical technology:
Process reliability to ISO 13485 and a perfect finish
In medical technology, uncompromising process control to ISO 13485:2016 standards is essential. We are well aware of this, having more than 20 years of experience in this sector. Product characteristics are rigidly defined, so as to ensure identical reproducibility.
We meet these requirements firstly thanks to our lean management standards. Secondly, we use ‘poka-yoke’ and ‘FMEA’, thus embracing a zero-defect culture: With our test planning, process planning and seamless documentation, we make production 100-percent traceable for our customers. We source raw materials exclusively from certified suppliers and only start mass production after comprehensive risk analysis. Our employees are specifically trained in the processes and requirements of medical technology, and regularly have to demonstrate their knowledge in tests. The production equipment is approved for medical technology,
giving us a basis on which to develop and manufacture components that meet the medical technology sector’s strict quality, precision and surface finish requirements. Here, our customers benefit from the fact that, as a one-stop shop, we cover and have a firm grasp of all the necessary areas of expertise in-house. To date, we have been able to demonstrate our expertise in manufacturing the following products, among others:
- Respiratory equipment
- Sterilisation vessels
- Implants
- Medical instruments
- Analyser components
- Dental technology products