Chip lifecycle / Medical lifecycle / Hardware & Chip Design and Implementation

Hardware & Chip Design and Implementation

Designing the custom chips, such as analog front ends, sensor interfaces, stimulation drivers and power management, and the boards and enclosure electronics around them, with risk controls implemented and verified at chip level, leading to chip tape-out and board design release under design control.

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

^O04 System, Chip & Software Architecture with Risk Controls

^A05 Hardware & Chip Design and ImplementationYou are here

^D06 Device Software Development to IEC 62304

Device, quality and regulatory milestones

Hardware, chip and software milestones

DIDesign inputs approved ARArchitecture and risk controls approved TOTR2Chip tape-out and board design release SRSoftware release for verification VRVerification readiness

Program and product management^A

Quality management system and design controls^DA

Systems engineering and requirements^AO

0.5

0.8

Medical chip design^A

0.5

0.8

1.0

Chip verification and safety analysis^A

0.5

0.8^A

1.0

Board and device hardware^A

0.5

0.8^A

Device software (IEC 62304)^D

0.5

0.8

Product cybersecurity^A

0.5

0.8

Electrical safety, EMC and compliance testing^A

0.3

0.5

0.8

Usability engineering and design validation^A

0.5

0.8

Manufacturing, test and supply^A

0.0

0.3

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: Hardware & Chip Design and ImplementationAI impactDisruption (red)Augmentation (blue)Opportunity (green)How AI is changing the workWhat the steps mean What the codes mean

Show this chart as a list

Stages

Device, quality and regulatory milestones

Hardware, chip and software milestones

Design inputs approved (DI)
Architecture and risk controls approved (AR)
Chip tape-out and board design release (TO) (technical readiness review TR2)
Software release for verification (SR)
Verification readiness (VR)

Disciplines

Program and product management^A
- System, Chip & Software Architecture with Risk Controls: maturity 0.3, Early draft. Design and development plan, schedule and review points approved, with the programme tracked against them through the design inputs and the architecture.
- 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.
Regulatory affairs^A
- System, Chip & Software Architecture with Risk Controls: maturity 0.5, Draft

Register or sign in to read on

The full lifecycle detail, with its charts, flows, tables and every section, is for registered members. Registration is free and takes a minute. You come back to this page afterwards.