If a device is designed to go inside the body, or if it contains medicinal substances, it is more likely it is treated as high risk. Depending on the risk classification, the law then imposes stringent standards to protect users from harm. These include obligations on the manufacturers and developers to ensure their devices are safe, through conducting risk impact assessments, periodic audits and other actions.
from Top Health News | Latest Healthcare Sector & Healthcare Industry news, Information and Updates: ET HealthWorld : ETHealthworld.com https://ift.tt/0ONwLl5
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