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Softwareentwicklung

ASQF e.V.

The ASQF is the largest specialist network for software quality in German-speaking countries and an important partner for developers, decision-makers and companies in the IT industry. More than 1,100 globally active companies, high-performing small and medium-sized enterprises, institutions of higher education and research institutes, specialists and students are members of ASQF. They all share the commitment to quality standards in information and communication technology.

Salino GmbH

We develop products, systems and solutions for well-known customers in the automotive, automation and health care industries. We identify all innovation potentials of a project in close cooperation with our customers. We develop ideas, work out strategies and establish successful market positioning. In addition, we support your product development processes or business model development. The basis of software development is a development process tailored to customer needs.

softgate GmbH

Since 1992, softgate's staff has grown to 90 employees and is a competent and reliable partner for the development and distribution of state-of-the-art and high-quality software solutions and services. Additionally, softgate's four company divisions Image Processing & Service Software, Embedded Systems, Document Capture & Management and Database Solutions provide an extensive and industry-independent solution portfolio. In close cooperation with strong international partners, the company distributes flexible solutions that are tailored to specific customer requirements.

Contact

Reinhold

SOHARD Software GmbH

SOHARD has been developing solutions for our customers in the field of medical technology for 25 years. We are focussed on the development of system software, firmware and embedded systems for CTs, MRs and linear accelerators. In the course of time, we have gained extensive knowledge, discovered new technologies and strengthened our product development. Thus, we are proud to be the first company worldwide to offer a Semantic PACS for clinical practice.

Contact

Peter Feltens

Würzburger Str. 197
90766 Fürth

+49-911-97341 0
peter.feltens@sohard.de
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4plus GmbH

4Plus provides state-of-the-art software engineering services. As an engineering firm with a staff of 80, we have been a successful provider of our services over the last fifteen years. The development of complex medical equipment and applications is our core competency. We develop X-ray-devices, lithotripters, lasers for dermatology and ophthalmology, driver and control systems for C-arms, surgical tables, embedded and PC applications and more. The 4Plus product solution add4Q is a quality suite for efficient requirement, test and documentation management.

LA2 GmbH

We develop critical software based on web technologies for the health care industry and provide consulting services to software companies in a regulated environment.

LA2 GmbH has developed critical enterprise software - based on web technologies - for the health care industry since 1999. LA2 does not only assist its customers with the implementation, LA2 helps its customers with specification and requirements gathering, project management and problems in the regulated environment (e.g. workshops/advice/certification for FDA 21 CFR Part 11 and EU GMP Annex 11).

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Marc Holfelder

Erfolgreich am Markt mit regulatorischem Zulassungsfahrplan

on 3. September 2014 - 11:22

Anfangs stellt sich Herstellern von Medical Apps die Frage, ob die App als ein Medizinprodukt im Sinne der FDA und MDD einzustufen ist oder nicht. Die infoteam Software AG unterstützt ihre Kunden bei der Einordnung ihrer App. "Falls es sich um eine App mit medizinischer Zweckbestimmung handelt, dann sind wir der richtige Partner für die Klassifizierung und Zulassung", erklärt Birgit Stehlik, Business Segment Manager Medical Devices bei infoteam.

Medizinprodukte mit Risikoanalyse nach ISO 14971

on 27. January 2014 - 16:14
In unserer zunehmend vernetzten Welt steigt auch die durch Software realisierte Funktionalität in medizinischen Geräten. Mittlerweile gibt es neben den klassischen Standalone-Medizingeräten, die aus einer Steuereinheit und einer Benutzeroberfläche bestehen, sogar mobile Apps für Smartphones, die aufgrund ihrer medizinische Zweckbestimmung ebenfalls als Medizinprodukt zu bewerten sind.