Clinical Safety

Clinical Safety

The Epilepsy12 audit engine does not have any role in the direct clinical management of patients, it is solely for recording the milestones in childrens' care for the purposes of national audit, which is a secondary use of data, not a direct care use. It does not therefore require a clinical safety case or a Clinical Safety Officer.

Medical Device Registration

The Epilepsy12 audit engine does not have any role in the clinical management of patients, it is solely for recording the milestones in childrens' care for the purposes of national audit. It is not a medical device and as such requires no medical device registration.