Especially in the field of regulatory affairs there are important steps necessary in early design phases, which are difficult to fulfil in retrospect.
We can develop high-quality individual software solutions, that are tailored to your given application systems, very efficiently by using state-of-the-art development and documentation tools.
In very rare cases one developer can be at the top in both fields. We have inhouse specialists for both fields.
Our software development processes are certified to ISO 13485 (quality management system for medical devices) and are controlled by a certified body every year. Bug tracking, feature tracking and source code versioning are as self-evident for us as code coventions required and compliant to the ISO 13485 standard. We can guarantee a very high software quality standard!
Certificate according ISO 13485
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Global HIV Vaccine Research Cryorepository
The systematic cryo-conservation of biologic material and the creation of according collections in cryo banks is highly important for industrial biotechnology and biomedical research. Examples for collected biological materials are stem cells for regenerative medicine in cancer research or in vaccine research for infectious deseases. In Sulzbach (Saar) the Fraunhofer IBMT runs a cryo bank with industrial scaling for research and for demonstration purpose. A trendsetting cryo technology platform has been developped and is in use and a highly valuable collection of vivid cells and tissues is craeted. Financed by the Bill & Melinda Gates Foundation the IBMT builds up a worldwide available HIV biobank for HIV vaccine research. Todays biobanks for biological material need a modern IT infrastructure that supports the internal sample tracking and the sample administration efficiently, that provides the services of a biobank for customers and partners and netwaorks it with further resources.
With new technologies and new methods to isolate stem cells Fraunhofer scientists started to archive the worldwide animal population. In cooperation with some zoological gardens Fraunhofer scientists collect stem cells of wild animals. The project is called „Cryo Brehm“ and was initiated in close connection with the UN biodiversity conference in Bonn. The goal of „Cryo Brehm“ is to collect stem cell samples of as many species as possible. To document existing species has allways been a challenge for scientists and is dedicated to the following generations. The german zoologist Alfred Brehm dealt with this subject in writing his famous book „Brehm´s Life of Animals“. The Fraunhofer Institute for Biomedical Engineering (IBMT), Saarland and the Fraunhofer Research Institution for Marine Technology (EMB), Lübeck chose the modern way. The technique they use is cryo conservation. Since the beginninng of 2005 alive-deposited genomes of various species are collected in this worldwide unique cell bank.
soventec developed a couple laboratory device adapters and modules for the PerkinElmer plate::works system by order of PerkinElmer.
plate::works is an intelligent automation control and scheduling system by PerkinElmer
SCRM - Cell-and Tissue Biobank (CTBB)
The SCRM-CTBB offers state-of-the-art infrastructure and technologies (e.g. cryogenic work bench, semiautomatic cryogenic storage system, uninterrupted cooling chain, innovative GMP Laboratory software Lab OS) and is structured into two areas, including research and a GMP/GCP regulated therapeutic applications.
State of the art Biobank an der Stellenbosch Universität, Kaptstadt
The Devision of Medical Virology at the Stellenbosch University under direction of Prof. Dr. med. Preiser has instantiated a state of the art biobank using Fraunhofer cryo technology. Safe SOP and workflow management is realized by the Lab OS, esp. the Lab OS Station.
soventec developed a couple of modules for the PerkinElmer Opera system within the company development team, esp. hardware close software components from stepper control, cameras and other analytical or controling units.
Opera is a high content high throughput confocal imaging solution by PerkinElmer.
soventec developed a couple of modules for the PerkinElmer Operetta system within the company development team, from hardware close software components from stepper control, cameras and other analytical or controling units to modern graphical user interface and database.
Operetta a high content imaging solution by PerkinElmer.
soventec developed a couple of modules for the Clarina II system within the company development team, from hardware close software components from stepper control, analytical or controling units to modern graphical user interface and database.
Clarina II is a single molecule detection system by Evotec (later Olympus MF-20).