Monday 24 January 2022

Risk Factors To Consider When Selecting Medical Devices For Pharmaceutical Applications



Using any medical device brings with it an element of risk at the clinical level, where risk represents the probability of occurrence of harm and the consequences of that harm (severity). While risks can be reduced to a residual level, it is not possible to eliminate a risk entirely. 


Such risks are foremost about injury to the patient and to the user and other persons, with the need to consider risk across the medical device life cycle. Other associated risks may be to the environment or with any data collected. The various risks are set out in ISO 14971.

It is incumbent upon the purchaser or distributor to assess a new supplier of medical devices for the relative risk to patients and users posed by these devices. This article assesses the common risk areas that require assessment.

Tim Sandle has published a new article, see: 

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (

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