A medical device, or a chip designed for one, from intended use and regulatory strategy through design controls, risk management to ISO 14971, software to IEC 62304, electrical safety and EMC to IEC 60601, usability engineering to IEC 62366-1, cybersecurity, verification and validation, regulatory submission and conformity assessment, design transfer, post-market surveillance and change control, to component obsolescence and end of support.
Medical electronics and medical device chips lifecycle: 12 stages, 16 gates of its own and 3 hand-offs to the Product lifecycle, from Intended Use, User Needs & Regulatory Strategy to Component Obsolescence, End of Support & Archive.
12 stages, 16 gates of its own and 3 hand-offs to the Product lifecycle, 3 of the gates technical readiness reviews (TR). Each stop opens its stage; each sign opens its gate. Point at a stop or tab to it to read what the stage is for. What the codes mean
In collaboration with The Digital Electronics Blog (opens in a new tab)
A dashed sign with a TR tag is a technical readiness review gate.
An outlined sign with an arrow is a hand-off: the gate is owned by the Product lifecycle, where this lifecycle hands its work on.
In collaboration with The Digital Electronics Blog (opens in a new tab)
Stating what the device is for, who uses it, on which patients and in which environment, and turning that into user needs, a first device classification in each target market and a regulatory strategy that says which route to market, which standards and which evidence the product will need.
Concept approval gate, owned by the Product lifecycle (Concept approval)Intended use and regulatory strategy approved gate
Planning the design under design controls inside a quality management system such as one built to ISO 13485: the design and development plan, the risk management plan to ISO 14971, the software development plan to IEC 62304, the applicable standards list, review points, responsibilities and the design history file structure.
An outlined sign with an arrow is a hand-off: the gate is owned by the Product lifecycle, where this lifecycle hands its work on.
Turning user needs into verifiable design input requirements, including essential performance, basic safety, electrical, environmental, usability and security requirements, while the first hazard analysis identifies hazards, hazardous situations and harms and the use specification describes users, uses and use environments.
Partitioning the device into hardware, chips, software and user interface, choosing risk control measures and placing them in the architecture, defining patient and operator protection and isolation, assigning a software safety class, writing the chip specification for any custom silicon and building the threat model.
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.
Chip tape-out and board design release gateTR2, technical readiness review
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.
Showing that design outputs meet design inputs: chip characterisation, hardware bench tests, software system tests, verification that each risk control is in place and effective, and type testing for basic safety and essential performance to IEC 60601-1 and electromagnetic compatibility to IEC 60601-1-2, usually at an accredited laboratory.
Verification readiness gateElectrical safety and EMC tests passed gateDesign verification complete gate
Showing that the finished device meets user needs and intended use in the hands of representative users, through the summative usability evaluation under IEC 62366-1 and design validation on production-equivalent units, with clinical evaluation evidence assembled where the route to market needs it, and the risk management report completed.
Assembling the technical documentation or premarket submission for each target market, such as a notified body review under the EU Medical Device Regulation or a premarket notification or other route with the US FDA, answering questions from the reviewer and obtaining the authorisation or certificate needed to place the device on the market.
Turning the verified design into reliable production: pilot builds, production test specifications for chips, boards and finished devices, process validation, supplier qualification and quality agreements, the device master record and unique device identification, ending in a controlled release to production.
Pilot build approved gateTR3, technical readiness reviewProduction release gate
Watching the device in use: complaint handling, trend analysis, vigilance reporting to authorities, corrective and preventive action, security vulnerability monitoring and patching, periodic surveillance reports, and assessing every design, supplier or component change for its effect on safety, performance and regulatory status before it is made.
Managing the end of the device and its parts: watching chips and components for discontinuance, planning last-time buys or redesigns, telling customers when service, spare parts and security updates will end, and keeping the design history and device records for the period the regulations and the device life require.
Obsolescence decision gate, owned by the Product lifecycle (Discontinuance decision)End of support gate, owned by the Product lifecycle (End of support)
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