Key's to Sucess: Safety, Effectiveness and Data/System Security

March, 1st-2nd, 2012, Charitè Central Campus,
Luisenstrasse 64, Berlin, Germany

The Symposium is addressed to decision makers from hospitals and Healthcare Delivery
Organizations (HDO's) like medical and administrative directors, CIO's and Quality Assurance
Managers. It is also dedicated to R&D, Compliance- and Product Managers
from Medical Device Manufacturers and providers of IT-Infrastructure and -Services.

The expectation of allmodern societies around the globe is the availability of safe and effective
health services. 80% of all upcoming Innovation in Health Information Technologies
(HIT) and Medical Devices (MD) is related to:

• Software in Medical Devices
• Software as Medical Device or
• Software for IT-Networks incorporating Medical Devices

PROSYSTEM FORUM SYMPOSIUM 2010

Fostered by the growing integration of Medical Devices in IT Networks, the philosophy of system responsibility has fundamentally changed. In future the Healthcare Delivery Organizations (HDO) of any system with networked Medical Devices will assume responsibility and liability, correspondingly. As a consequence of that, the HDO (e.g. hospital, telemed center) has to envisage new tasks which include an upgrade and expansion of the established Quality and Risk management System. New competences and job descriptions are required. In future integration of medical devices into IT networks (MIT) will become an indispensable core competence of a hospital and the basis for cost reduction and competitive advantage. To establish this new competence, a corresponding strategic planning and the establishment of special knowhow is essential. To better safeguard their own interests and in order to identify forward-looking technical and organizational trends in the healthcare sector, it will be unavoidable to implement the key properties required by IEC 80001-1: Safety, Effectiveness, and Data and System Requirements.

Software as an integral part of a medical device, as well as software as a medical device in its own right has to fulfill additional requirements which apply to the complete software development life cycle. Medical device manufacturers are responsible to follow these requirements for all kind of medical device software. Amongst others this includes a software risk assessment as well as verification and validation activities during and after the software development phase. FDA and other regulatory authorities demand a structured approach for medical software development. The IEC 62304 standard describes the software development life cycle and guides medical device manufacturers through the software development process.

The aim of the PROSYSTEM Symposium 2010 was to present the new requirements of IEC 80001-1 for hospitals, medical device manufacturers, as well as for IT Vendors as a first hand insight by inviting key speakers involved in the development of this new IEC safety standard. On the second symposium day the speakers provided detailed reflection on experiences applying IEC 62304 for medical device software including an outlook on a future revision in the standard. 70 participants attended the 2010 symposium and benefited from the over 10 year experience of PROSYSTEM Forum in organizing such events.

 Download Symposium Brochure here:

 Participants can download the symposium presentations here.