Plasti-med has long been accustomed to operating in a highly regulated environment with regards to design and development of medical products. All Plasti-med devices are manufactured to the highest possible standards and have been bearing the CE mark since 2003 – demonstrating compliance with the Medical Device Directive 93/42/EEC. The Plasti-med Quality Management System is certified according to and regularly audited against ISO 9001:2015 & ISO 13485 (2016). It is this commitment to Quality Assurance which enables us to serve and satisfy all our customers’ expectations..