Regulated testing

In many industries, a bug may be an inconvenience or perhaps delay something a user wants to do. Still, the results of such a bug would hardly be considered life and death. In some industries, however, death could be the consequence if a bug slips through. Think of the software that controls jet aircraft or marine shipping vessels. Think of medical devices. In financial software, if a bug were to be introduced, this could have catastrophic financial implications for an organization. These are areas where a much higher standard is applied and thus, regulations are in place to ensure that these organizations are offering the safest possible product with a minimal chance of failure.

Navigating regulatory requirements

Regulatory requirements typically spell out the types of testing needed, the documentation that must be written and followed, and the exact steps that must be followed to comply. The US Food and Drug Administration (FDA) uses IEC 62304 (https://www...