Aligned AG

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I explore the best practices in fast and efficient medical device development documentation, attempting to re-channel resources from documentation and administration to real innovative medical device development. By scrutinising methods and approaches used in the medical device development when applying norms and standards like ISO 13485, ISO 14971, IEC 62304, IEC 62366 etc., great savings can be made by simplifying and rationalising the processes used. I also demonstrate how this can be achieved using Aligned Elements - our medical device ALM software.

iso 14971 traceability risk priority number fmea har hazard alarm failure mode risk summary alap technical file ivd-d design controls mdd templates qms design history file signatures quality management system administration fda qsr 820 dhf iso 13485 medical device documentation risk assessments aligned ag alm rpn medical device probability conventions severity architecture risk management alm medical devices preliminary hazard analysis iec 62304

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Aligned AG

Präsentationen

Applying IEC 62304 Risk Management in Aligned Elements - the medical device ALM

ISO 14971 Risk Management - how others do it

Death by documentation - Medical Device Development Challenges