raithel & koerner is a consulting business with a focus on medical devices and textile technology. With significant experience from a variety of projects ranging from product development to regulatory affairs, we strive to implement perfectly tailored solutions for our customers.
Medical Devices
Product development, process validation, risk management, test methods, statistics, design of experiments or quality management? Still not sure how to meet EU 2017/745 requirements or how to implement UDI direct marking?
We may be able to provide just the perfect service.
Operating Room with gear
Quality Management
ISO 9001 and ISO 13485
Design and Implementation of Management Systems, Requirements Engineering and Business Analysis, Risk Management, Corrective and Preventive Actions, Auditing, CAQ and QMS on MS Sharepoint - we did it.
Our experience with smart approaches to Quality Assurance and Quality Control helps to minimise testing.
Statistics
Textiles
We provide support in the development and application of processing technologies for high tech fabrics such as protective gear, surgical meshes and OR fabrics. We are familiar with the specific test requirements and statistical tweaks for continuous products (fabric) and the each (garment).
Looking for a supplier or a textile testing partner? We can help.
Mesh