Medical software

Question 1

What is IEC 62304

Answer 1

IEC 62304 is an international standard describing general principles of SW validation. (came out in 2006, revised in 2016). Recommends SW validation and verification activities to be conducted throughout the SW life cycle stopping short of recommending any particular model. Compliance with IEC 62304 is required by regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Union’s Medical Device Regulation (MDR) for the development and commercialization of medical devices that incorporate software.

Question 2

what is a life cycle

Answer 2

a conceptual structure spanning the life of the SW from definition of its requirements to its release. (set of steps)

Question 3

example of bad life cycle

Answer 3

code -> fix

Question 4

life cycle classification:

Answer 4

waterfall: one shot process from customer needs to delivery
incremental: customer needs and requirements done once, then multiple development cycle to add capability
evolutionary: user needs cannot be understood up front, so requirements cannot be fully defined, in each iteration revisit the whole process

Question 5

agile steps

Answer 5

1. story
   2.

Question 6

what is design control discipline

Answer 6

1. must operate ‘under control’
2. if during implementation we find problem with design:
   stop implementation
   fix design
   resume implementation
3. we do not continue with the implementation and make on the fly decisions without updating the design.

Question 7

at each stage need to demonstrate

Answer 7

1.efficacy
2. safety
3. security

Question 8

tension between what and how

Answer 8

what - keep the grass short
how - piece of equipment to accomplish this

Question 9

the brown cow model

Answer 9

how now (concrete, current situation) –> what now (abstract -essential business use case)–>what future(abstract) ==