Conferences & Events

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Past

October 10, 2012 - Synergus will organize a conference about Local Reimbursement and Funding of Medical Devices in Germany on Wednesday 10 October 2012, at Charité in Berlin. More information will be published once the agenda is set.
German conference 10th of October 2012

Registration

Risk management for Medical Devices software

Jun 07, 2010
Amsterdam, The Netherlands

IEC/ISO-62304, ISO-14971, IEC-80002 and the revised Medical Device Directive

The Medical Device Directive has emphasised the need for having an integrated SW Risk Management process when developing Medical Devices.

“For devices which incorporate software or which are medical software in themselves, the software must be validated according to the state of the art taking into account the principles of development lifecycle, risk management, validation and verification.”

Synergus offers a 2-day hands-on course to understand the process for Software Risk Management based on the IEC/ISO-62304, ISO-14971, IEC-62366 and IEC-80002.

The course will be held by of Synergus experts in Risk management, Mats Petersson and Robert Ginsberg, who was one of the co-authors of IEC/ISO-62304.

Each occasion will be limited to 30 participants to allow for interaction during the course.

Conferences & Events

Risk management for Medical Devices software

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