Validation

Endoss takes a pragmatic approach to validation, with the goal of carrying out the most efficient validation possible that causes the least amount of burden on the department. Because our validation method also features a shorter lead time, measurement results come in quickly and the machines are always ready for use. The applicable standards such as EN ISO 15883, EN285, ISO 17665 and ISO 16442 are our guide. National guidelines are incorporated where desired or necessary – and obviously always in consultation with the client. Being independent means we get to see many different reprocessing solutions which enables us to have an open mind and neutral view on the different approaches. We have unique knowledge in the field and we work with innovative tools to carry out efficient validations.

Our staff represents over 50 years of experience in Validation and Qualification in a medical environment. We have the skills and experience to validate well known manufacturers such as Wassenburg, Olympus, Steelco, Miele, STERIS, Cantel, Medivators, Getinge, MMM, Soluscope, BHT, Belimed, Tuttnauer, etc. By working closely with these manufacturers we are able to perform rapid and professional validations. For microbiological results and cleaning tests we work together with Munich-based Simicon GmbH. Serve Medical Ltd supplies more specific tests, such as biofilm and culture media. For water and air samples, we occasionally work together with local suppliers in order to keep your costs as low as possible. EBRO GmbH in Ingolstadt is our primary supplier of measuring equipment for pressure, temperature and conduction. EBRO supplies an electronic Bowie and Dick test which is calibrated annually. Wireless measurements are an option for most validations.