This blog post explains the value of this kind of surveillance and where the new document fits in. All medical devices carry residual safety and performance risks throughout their lifecycle.
These stem from a combination of factors that include product variability, factors affecting the product’s use environment and different end-user interactions, as well as unforeseen device failure or misuse. You can also find more information on various medical devices if you are looking for one for your medical faculty.
Of course, product design and development activities are designed to ensure that any residual risk is acceptable before product release.
Notwithstanding, it’s important to collect and analyze information both during production and post-production to make sure that residual risk remains acceptable.
This activity can result in the early detection of undesirable effects and can reveal opportunities for product improvement.
To help manufacturers perform appropriate post-production monitoring, ISO has produced ISO TR 20416:2020 Medical devices. Post-market surveillance for manufacturers.
Proactive and systematic
ISO TR 20416:2020 is an international technical report. It describes a proactive and systematic process that manufacturers can use to collect and analyze appropriate data.
It will help establish a common understanding of the post-market surveillance process. Also, the process described is consistent with relevant international standards, in particular ISO 13485 and ISO 14971.
Post-market surveillance typically links to other processes that have been established in the quality management system.
Post-market surveillance activities help ensure that available data is analyzed and used to make determinations about product safety and performance in accordance with the intended use.
This type of surveillance contributes to meeting regulatory requirements. ISO TR 20416 contains suggestions and techniques that can be used to meet applicable regulatory requirements.