ISO compliance

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 how the devices shall be packaged to allow sterilization and ensure that they remain sterile.