Kanwal Jit Singh EN ISO – Content Deviation # 3 – IS IT IN TUNE WITH EU REGULATORY FRAMEWORK Content Deviation # 3 reads as follows Risk reduction 'as far as possible' versus 'as low as reasonably practicable': a).

IMSXpress 14971 Medical Device Risk Management software is a Windows application for implementing Risk Analysis, Risk Evaluation, and Risk Control in strict compliance with the ISO standard. • Risk analysis, risk evaluation, and risk control methodologies strictly follow requirements of ISO 14971 and all recommendations included in ISO 14971 Annex B through E. • Reports generated by IMSXpress comply with ISO 14971 requirements for Risk Management File (Clause 3.5) and provide most of the content required for that file. PDF Reports generated by IMSXpress comply with ISO 14971 requirements for Risk Management File (Clause 3.5) and provide most of the content required for that file. There is even an approval signature page, so that the report is ready for publishing as a controlled document and/or for submitting the study to your regulatory agency. A full report includes the following sections: • Title Page • Risk Matrix • Table of Contents • General Information • Approvals (signature page) • Risk Matrix • Risk Study Summary Report • Risk Study Detailed Report • Appendix 1 - Generic Hazards • Appendix 2 - Considered Uses and Safety Characteristics.

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All rights of this EN ISO 14971:2012 file is reserved to who prepared it. Team-nb ref.: team -nb positionpaper en iso.docx page 2/ key questions will include: 1.

Are all design solutions conform with the safety principles giv en in 14971 Last Update: 4 year ago.