GUEST OPINION: In software development and quality assurance, ensuring every requirement is tested and accounted for is critical. A Requirements Traceability Matrix (RTM) is a document that maps user ...

Nine requirements management tools for medical device development ranked by traceability, compliance support, and regulatory readiness for FDA and EU MDR.

DO-254 enforces a strict requirements-driven process for the development of commercial airborne electronic hardware. For DO-254, requirements must drive the design and verification activities, and ...

Traceability is becoming increasingly important in most engineering projects, if only on the grounds of ‘good practice,’ and it is specifically required for projects that have to meet safety standards ...

In May 2021, Europe’s medical device regulation (EU MDR) will go into effect, replacing the existing medical device directive (MDD) that is currently in place. The impact of this regulatory change in ...