ISO 13485: Risk Management »
Risk Management and the ISO 13485
Clinical Evaluation and Risk management – Interesting Inputs for the Design Phase
Risk management and clinical evaluation; two important topics that are critical for the release of the medical device – no doubt about it. In this article I am bringing some facts about the relation
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ISO 13485 and Risk Management – Critical Relations of the new kind
The Iso 13485:2016 takes the integration of risk management in the realization activities one step forwards by demanding the definition, documentation and implementation of risk management system in the quality management system. In this
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ISO 13485: Risk Management integrated in the Design and the Development
In clause 7.3.2—Design and development planning, the organization is required to maintain a plan to control the design and development of the medical device. This plan will include process elements like a systematic process
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