Device Specifications Template
The Device Specifications Template is a sample as to how to record complete specifications of the device. ENG104-3 DEVICE SPECIFICATION (EXAMPLE) is a specific document that briefly describes and gives all important details of the external and optionally internal characteristics of a device.
Generally a product specification will contain the device’s:
- product trade and common name(s);
- intended use(s);
- performance characteristics and theory of operation;
- regulatory classification;
- physical characteristics;
- environmental limitations and product stability;
- important components and formula (if applicable);
- manufacturing cautions; and
- user safety characteristics.
A preliminary device specification should be written at the beginning of a project and updated as the device is developed or modified. Specifications are usually developed by the marketing and product development departments with review and consultation by quality assurance, manufacturing, and other departments. The contents of the final specification must agree with the other elements of the device master record and with the actual device when it is manufactured.