This is just a small sample of the many requirements and activities that are included in the IEC 62304 standard. The checklist would be much longer and more detailed, covering all the necessary requirements and activities for the software development lifecycle.
Dr. Maria Rodriguez, a seasoned medical device software engineer, had just been assigned to lead a project to develop a new software-controlled infusion pump. The pump would be used to deliver precise amounts of medication to patients in hospitals and clinics. Iec 62304 Checklist Xls
| | Description | Done | | --- | --- | --- | | 5.1.1 | Software development lifecycle processes | | | 5.1.2 | Software planning | | | 5.2.1 | Requirements analysis | | | 5.2.2 | Requirements validation | | | 6.1.1 | Design | | | 6.1.2 | Design verification | | | ... | ... | ... | This is just a small sample of the
Here's an example of what the checklist might look like: a seasoned medical device software engineer