Monthly Archives: August 2018 »
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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Challenges manufacturers of medical devices are facing when implementing labels under the ISO 13485
Labeling refers to the identification of the medical device during its lifecycle. Labeling the medical device is a challenging task for manufacturers in an ever-complicated environment. And the activity of printing and assembling the
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