What is a software product framework?

January 24, 2021

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 62304:2006This 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]

https://www.iso.org/obp/ui/#iso:std:iec:62304:ed-1:v1:en

Author: Alix Auter, Life Science Consultant KVALITO 

KVALITO is a strategic partner and a global quality and compliance services 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.

You May Also Like…

Precision Medicine

Precision Medicine

Precision Medicine Precision medicine, also known as personalized medicine, is an approach to developing safer novel...

How is a system validated?

How is a system validated?

Definitions from ISO 9000:2005, revised by ISO 9000:2015 Quality management systems – Fundamentals and...

Usability and Labelling

Usability and Labelling

What is usability ?   The new Regulation, MDR, strengthens the rules regarding labelling and...

Pin It on Pinterest

Share This