Requirements and Usability - Garza MD

Usability

One of the key competences of Garza MD is the usability engineering process. This not only because of a university background of the consultant in product design but also because of a 10-years working experience in this field.

The usability engineering process needs to be flexible and documented. Traceability is a mandatory requirement required. And the  The process can be scaled according to your needs. Garza MD can advice and guide you in this process and customize it to your needs specific situation.

EN 62366 sets out a usability engineering process for medical devices that helps to design straightforward and efficient user interfaces. These, in turn, will minimize user errors and hence reduce risks.

Requirements engineering

Garza MD offers support for setting up the required documents for the design history file of a medical device. This includes traceability of requirements and requirement changes, tests, verification and validation. Garza MD can also support in the implementation and application of a lifecycle management software tool (e.g. requirements management).

Software lifecycle

Software is often, if not always, an integral part of an active medical device, or it can be a medical device of its own.

Garza MD has many years of experience with medical software projects. Garza MD can support in the setting up of a software development process based on EN 62304 and / or EN ISO 13485 .