Chip lifecycle / Medical lifecycle / Device Software Development to IEC 62304

Device Software Development to IEC 62304

Developing the firmware and device software under the IEC 62304 software lifecycle for its safety class: detailed design where the class requires it, unit implementation and verification, integration and system testing, management of software of unknown provenance, the software bill of materials, security testing and a controlled software release.

Where this stage sits

This stage with its neighbours. Each row is a discipline active here, shaded by how mature its work is by the end of each stage.

Stage

^A05 Hardware & Chip Design and Implementation

^D06 Device Software Development to IEC 62304You are here

^A07 Design Verification: Function, Electrical Safety & EMC

Device, quality and regulatory milestones

Hardware, chip and software milestones

ARArchitecture and risk controls approved TOTR2Chip tape-out and board design release SRSoftware release for verification VRVerification readiness STElectrical safety and EMC tests passed VCDesign verification complete

Program and product management^A

Quality management system and design controls^DA

Systems engineering and requirements^AO

0.5

0.8

1.0^D

Medical chip design^A

0.8

1.0

Freeze

Chip verification and safety analysis^A

0.8^A

1.0

Board and device hardware^A

0.8^A

1.0

Device software (IEC 62304)^D

0.5

0.8

1.0

Product cybersecurity^A

0.5

0.8

1.0

Electrical safety, EMC and compliance testing^A

0.5

0.8

1.0

Usability engineering and design validation^A

0.5

0.8

Manufacturing, test and supply^A

0.3

0.5

Post-market surveillance and field quality^A

0.0

Key0.0Planned0.3Early draft0.5Draft0.8Feature complete1.0CompleteFreezeFrozenFaded block: still at the step shown before it, Held below Complete or Maintained under change control once complete or frozenFreeze or sign-off pointMilestone for one item; the rest of the work carries onMilestone gateTRTechnical readiness review (TR): a gate that checks the technology is ready before the next commitment.You are here: Device Software Development to IEC 62304AI impactDisruption (red)Augmentation (blue)Opportunity (green)How AI is changing the workWhat the steps mean What the codes mean

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Stages

Device, quality and regulatory milestones

Hardware, chip and software milestones

Disciplines

Program and product management^A
- Hardware & Chip Design and Implementation: maturity 0.5, Draft. Design implementation and verification tracked across hardware, chip and software, with test laboratory slots and usability studies booked.
- Device Software Development to IEC 62304: maturity 0.5, Draft. Design implementation and verification tracked across hardware, chip and software, with test laboratory slots and usability studies booked.
- Design Verification: Function, Electrical Safety & EMC: maturity 0.5, Draft. Design implementation and verification tracked across hardware, chip and software, with test laboratory slots and usability studies booked.
Regulatory affairs^A
- Hardware & Chip Design and Implementation: maturity 0.5, Draft

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