OntoPMS: OntoPort is member of a consortium in a SME-project funded by the German Federal Ministry of Education and Research (https://www.bmbf.de/en): “OntoPMS” support code 01IS15056D. The project started in January 2016 and will run for two years.The project aims at the “Development of ontology based software for post market surveillance (PMS) of medical devices based on data from manufacturers, legal bodies and internet based sources”. OntoPort is one of the technology partners and responsible for working packages “Preliminary investigations focussing on data integration of third party sources”, “Basic structures and functions”, “Development of visualisation components”, and “Integration of the MAUDE database and other relevant sources”. OntoPort will actively participate in almost all other working packages of the project. Wolfram Bartussek is the project lead for OntoPort. Members of the consortium are IMISE (University of Leipzig, https://www.imise.uni-leipzig.de/en), the Federal Institute for Drugs and Medical Devices (http://www.bfarm.de/en), novineon Healthcare Technology Partners GmbH (consortium lead, http://www.novineon.com/), Ovesco Endoscopy AG (Manufacturer of medical devices, http://www.ovesco.com/), and two more technology partners IntraFind Software AG (http://www.intrafind.de) and MT2IT GmbH & Co. KG (http://www.mt2it.com). The project is supervised by DLR (http://www.dlr.de/en) and served by PMGB Grosser (http://www.pmbg.biz).
OntoVigilance: The European directive 93/42/ECC concerning medical devices aims at promoting a common approach by manufacturers and Notified Bodies involved in the conformity assessment procedures according to the relevant annexes of the Directives, and by the Competent Authorities charged with safeguarding Public Health. They have been carefully drafted through a process of consultation with various interested parties during which intermediate drafts were circulated and comments were taken up in the documents. Therefore, they reflect positions taken in particular by representatives of Competent Authorities and Commission Services, Notified Bodies, industry and other interested parties in the medical devices sector. The guidelines are not legally binding. It is recognised that under given circumstances, for example, as a result of scientific developments, an alternative approach may be possible or appropriate to comply with the legal requirements. Due to the participation of the aforementioned interested parties and of experts from Competent Authorities, it is anticipated that the guidelines will be followed within the Member States and, therefore, ensure uniform application of relevant Directive provisions. Guidelines are subject of a regular updating process. To achieve compliance with this directive the German Federal Ministry of Education and Research funds a research project “OntoVigilance” (Förderkennzeichen: 01IS12038C) where Wolfram Bartussek is participating as IT coordinator. more …
Synthetron Reporting Server: As an innovative approach Synthetron conducts time limited and moderated discussions on key issues of todays organisations. The participants decide what is important free of peer pressure, social concerns or politics. Synthetron allows constructive listening to large and dispersed groups – a communication option previously only possible as a “message from the top”. The Reporting Server is designed for technical data analysis resulting from sessions with up to 800 participants. It then produces automatically the required reports by fundamental statistical analyses using the open source package R. more …
