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.

The guidelines for clinical investigations involving medical devices emphasize ethical considerations, prioritizing the protection of human subjects' rights and well-being. They outline the requirements for clinical investigation plans, define the roles of sponsors and principal investigators, and incorporate risk management principles to ensure compliance and data integrity throughout the research process.

It defines terminology and specifications for measuring feet and determining footwear sizes, including dimensions like length, width, and heel height. This standard ensures that footwear complies with required sizes for comfort and functionality, facilitating proper shoe assembly and marking.

It specifies methods for determining the attachment strength of footwear straps, trims, and accessories, ensuring that components like straps and eyelets remain securely fastened during use. The standard outlines procedures for testing the strength and durability of these attachments under specified conditions, establishing minimum performance requirements to withstand typical stresses encountered during use, which is crucial for the safety and functionality of footwear.

It focuses on assessing the resistance of footwear materials to crack initiation and growth through a belt flex method, evaluating their durability under repeated flexing. This standardized approach ensures that materials meet safety requirements, and the device will comply with these standards to guarantee its safety and performance.

It specifies a method for testing the slip resistance of personal protective equipment (PPE) footwear, focusing on various test modes such as forward heel slip, backward slip on the forepart, and forward flat slip. This standard ensures that footwear can withstand different surface conditions, providing essential safety against slips and falls during use.