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beat steffen, of confinis ag, has been nominated to develop and lead a one-day public seminar at ARIAQ, a leading quality management training centre in yverdon-les-bains, switzerland. the event, to be held on 9 november 2011, will cover the regulatory and normative requirements regarding the development of medical device software, with a focus on europe and the US. software lifecycle management is increasingly important in the medical devices field, and it is a key requirement for those working in this area to understand the process and documentation needs of notified bodies and other authorities.
more information: www.ariaq.ch/images/stories/PDF/fiches/A/a3810.pdf
visit here the confinis presentation, pages 96-97
after a successful initiation in 2009, this year’s medbraid medical devices seminar will focus on “development – manufacturing – release”. here, confinis’ beat steffen will offer a “tips and tricks” forum with regards to implementation of software lifecycle management processes according to the EU harmonized and FDA recognized consensus standard IEC 62304. the event will take place on the 6th of september at the radisson blu hotel (next to the zurich airport). for more information please visit the medbraid website at: www.medbraid.com
another event of the saq (swiss association for quality) – section medical devices with the title GAMP5 und FDA CFR 21 Part 11 will take place on february 19th 2009 in olten. thanks to his expertise and proven track record, mathias eng, partner at confinis ag, has been invited to present these two subjects. for more information please visit: http://www.saq.ch/de/events/detail/324/
this year’s forum - institute for management gmbh seminar with the title “medical devices in switzerland” will take place on the 17th of february 2009 in basle / switzerland. thanks to his expertise and proven track record, beat steffen, managing director and partner at confinis ag, has been invited to present "risk management for medical devices". for more information please visit: http://www.forum-institut.de/fileadmin/pdf/0902255.pdf
this years medconf 2008 convenes from the 23rd to the 25th of september, in munich, under the title "software and system design for medical devices". mathias eng, partner at confinis, has been invited to present at medconf 2008: "sw lifecycle process based on IEC 62304 including risk management for software in accordance with ISO 14971". for more information please visit www.medconf.de/anwenderberichte/confinis/
in recent years, confinis has successfully developed, introduced and trained software lifecycle processes in accordance with IEC 62304 for several companies of various sizes. from these varied work experiences , confinis has acquired the unique know-how to position itself as a market leader. special attention and focus continues to be given to the close connection with the risk management process according to ISO 14971. in addition to customer–tailored documented procedures, templates have been developed in conformance with international standards. our customized templates assure a consistent approach and guarantee compliance with the above mentioned standards and include: software quality planning, software requirements specification, software design descriptions, software verification and validation, traceability analysis, requirements engineering and management, usability engineering for software, configuration management and software change management).
confinis today announced that mathias eng will join the confinis team as a senior consultant and partner. mathias will provide professional and advisory services to our clients in the healthcare industry.
"this is a stroke of luck for us, as mathias has tremendous experience in the medical device and diagnostic industry! moreover, he was already freelancing for confinis for the past two years." the management of confinis gladly mentioned.
prior to joining confinis, mathias was working for csa engineering ag as a project manager in switzerland and abroad. here, mathias oversaw numerous projects in regulated environment (medical-electrical devices with software, equipment for production including qualification, process validation, computer system validation incl. incorporation of 21 CFR Part 11 requirements) from the idea over design, realization, verification and validation to successful market launch.
it is with great excitement that confinis announces its start of the first project for a pharmaceutical company in china. this project – consisting of developing and introducing policies and standard operating procedures – will take place in the greater shanghai area. to optimize the confinis global team, we have brought on board a native mandarin and cantonese speaking consultant.
ISO TC 210 and IEC 62A agreed to initiate project IEC 80002 medical device software - guidance on the application of ISO 14971 to medical device software. the first work group meeting will take place in may in dresden / germany. beat steffen and joerg dogwiler representing switzerland, will play an active role in the development of this standard since the standard completion will impact one of confinis’ core competences.
today, confinis was awarded its international registration for grant of protection in the european community by the WIPO (world intellectual property organization). after previously receiving grant of protection in switzerland in 2006, this recognition by WIPO represents another milestone in the history of confinis.
confinis today announced that joerg dogwiler will join the confinis team as a partner, effective september 1, 2006. mr dogwiler will provide professional and advisory services to our clients in the healthcare industry.
"we are very excited that joerg has accepted his new challenge", said beat steffen and samuel lainez, current partners at confinis. "having joerg's knowledge, leadership skills, creativity and expertise in medical devices on board will help us to expand our company as well as our client services portfolio and keep the strong growth."
prior to joining confinis, joerg was a product development project manager in the medical devices field (product, process and test system development, qualification and
validation activities) with zühlke engineering ag. he also held various management
positions at abb and apag. joerg holds a master of science in electrical engineering from the renowned swiss federal institute of technology (eth).
confinis ag and confinis usa (formerly AIT) today announced to enter a strategic alliance. this represents an important milestone in the history of both companies and will significantly expand the diversity of offered services.
both confinis ag and confinis usa experience an increased demand from international
companies in medical device, pharmaceutical and biotech industries particularly
in managing intercontinental projects. by joining forces we are able to offer
additional services in both the european and american continents supported
by a network of professionals and diversified expertise.