Monthly Archives: September 2018 »
ISO 13485 Standard:2016 – 8.3.4 Rework
Rework in the eyes of the ISO 13485 Standard is considered the performing of an action on a nonconforming product or service needed to eliminate a detected nonconformity and to make the Medical device
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ISO 13485:2016 Standard – Maintaining documented procedure for Human resources
Human resources is considered a resource for the realization of an Medical device product, its components, or related services and has objectives that are derived from the type of the Medical device, the strategy
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7.3.7 Design and development validation – Objectives
Did you design the right Medical Device? This is the main question that design and development validation needs to answer. design validation refers to the sum of all efforts necessary to ensure that the
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ISO 13485 – 5.4.1 – Quality objectives
Quality objectives have a strategic role of carrying out the quality policy and its implementation through a quality management system and provide a means to assess whether the QMS achieves its goals. The effectiveness
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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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