A software product framework is a set of software units assembled in a software item. The collective software items form the software system. The software system, together with the packaging and the instruction for use, shape the software product.
The International Electrotechnical Commission (IEC) is an international standards organization that prepares and publishes international standards and technical specifications for all electronic, electrical, and associated technologies – collectively known as “electrotechnology”. See: IEC 62304:2006. This regulation, [1] in section 4.3, defines software safety classes, based on severity (not probability) of risk:
– Class A: No injury or damage to health is possible
– Class B: Non-SERIOUS INJURY is possible
– Class C: Death or SERIOUS INJURY is possible
The FDA proposes a similar classification (minor, moderate, major).
The classification may change when an external risk control measure is implemented to the software.
Reference[1]
Author: Alix Auter, Life Science Consultant KVALITO
KVALITO is a strategic partner and a global quality and compliance service and network for regulated industries. To learn more about our service please visit us on www.kvalito.ch
If you would like to benefit from KVALITO’s specialized services, please get in contact: client.partner@kvalito.ch.
