This standard specifies requirements for all entities involved in medical devices, in all stages of the product life cycle: from design to manufacture to installation to disposal. Ubora Platform is structured to be a guideline for design activities in compliance to this standard.
This standard specifies requirements for designers and manufacturers of medical devices, in order to minimize the risk of the device itself. There is no “risk zero” device but many activities can be implemented to reduce and manage risk. This standard provides useful checklists and also guidance on the most widespread risk management techniques such as FMEA.
This guideline provides information on methods used to assess the clinical performance and the clinical benefit of a medical device.
This standard provides guidance on how to manage the human factors while designing a medical device (usability engineering).
This standard lists a series of symbols that may be applicable in labels of medical devices.
This standard specifies requirements for electromedical devices; it has more than 60 related publications, that describe very specific areas of electromedical devices.
This standard specifies how to design and code software for medical devices and sets requirements for SW change control.
This standars is a family of standards aimed at creating a common framework for assessing software product quality.