An independent, ISO 13485 certified, microbiological laboratory focussing on tests of Medical Devices in relation to sterilization validation. The management of Micro-Serve consists of Esther Broekmaat and Kees Frémery. They both have more than 10 years of practical experience in the industry of sterilization validation and have a high level of knowledge of the applicable standards. Their services include validation studies (ISO 11137-2), routine bioburden tests (ISO 11737-1), routine sterility testing (ISO 11737-2), accelerated aging studies (ASTM F1980-1999), monitoring of clean rooms and production locations, advice in validation methods, and writing validation protocols.
Crefact consultants are in contact with an extensive network of reimbursement consultants throughout Europe. We support companies during market access procedures and the introduction of healthcare services and concepts on the European market. Crefact is based in the Netherlands. Here we focus on strategy development, reimbursement trajectories, and implementation and project management within the Dutch healthcare sector. Among the customers are companies in the field of medical technology, healthcare providers and governmental organizations.
Net-Translators is a leading translation and localization company offering services in over 60 languages to medical device and software companies around the world. We specialize in medical translations – certified for ISO 13485: 2003 – Quality Management Systems for Medical Devices and we serve three of the biggest medical device manufactures in the world – Medtronic, J&J and GE Healthcare.
Services include localization of GUIs and online Help, translation of technical and marketing documentation and full website globalization.