Good Design Practice for Medical Devices and Equipment : Requirements Capture

Due to the direct health and safety effects they have on users, medical devices are subject to many regulations and must undergo extensive validation procedures before they are allowed on the market.

Requirements formulation is one of the most important aspects of the design process because it lays the foundation for the rest of the design.

This workbook explains a method for capturing requirements.

It does not provide information on how to gather information and perform background research.

Rather, it details how to organise information that has already been gathered into a requirements specification.

The method involves three phases: defining the problem and the business requirements; determining and detailing the functions required to satisfy the problem; and documenting the results in a requirements specification.

Three tools are provided to facilitate the above process: functional analysis - for determining functional and performance characteristics; matric checklist - which covers a wide range of requirements including reliability, safety and documentation; and regulatory guidelines - information on regulations and standards. This workbook is intended to be used by medical device designers, engineer and project managers, and procurement officers.

Pervious experience in writing specificaitons is not necessary, but experience in medical device design is likely to be helpful.