Quality and Regulatory Affairs Consulting

Medicoplast International GmbH

Illingen, Germany

Medicoplast International GmbH is a medium-sized company with over 45 years of experience in medical technology. With approx. 80 trained employees, we develop and produce medical disposables made of silicone, latex, polyurethane, polyvinyl chloride and other plastics. The product range includes catheters, drains, tracheal and tracheostomy tubes, feeding tubes, cannulas as well as extensive accessories in the respective fields of application. Our company is located in Illingen, directly on the A1 freeway; in the country corner France - Benelux - Germany. We sell more than 40 million catheters annually through a worldwide dealer network with long-term partners. Our catheters are manufactured with special automatic production machines designed by Medicoplast itself. Manual work is essential for various production steps and special products. In order to meet the high hygiene standards for medical products, we manufacture our products in an ISO Class 8 clean room (DIN EN ISO 14644). The packaging into the sterile barrier is done by validated packaging machines in our clean room. Various formats and designs are available so that we can handle any request from our customers. We work hand in hand with our customers and medical professionals in the development of medical devices. Medicoplast draws on the experience of more than 45 years of development and processing of plastics in medical technology. In order to be able to realize complex products, we work with modern design software in 3-D representation, as well as 3-D printers for the production of models and samples. With our in-house injection molding and extrusion machines, Medicoplast can fulfill all aspects of medical device production. Medicoplast's sterilization facility sterilizes products using the ethylene oxide process, which is gentle on materials. Our quality and product management staff look back on many years of experience and receive ongoing training to meet the high regulatory requirements for the products.