Medical device development Gantt chart with design reviews and V&V
An editable medical device development Gantt chart: design inputs, design and development, verification, validation and design transfer, with a risk file kept in step and milestones for each gate.
What the medical device development gantt chart with design reviews and V&V process is
Device development goes wrong in the joins between stages. Design inputs are loose, so the design drifts. The risk file is updated at the end rather than alongside the design. Test protocols are written after the prototype exists, so they test what was built instead of what was required. Verification finds a failure and nobody planned time to fix it and retest. A timeline cannot prevent these, but it shows where each of them would land on the calendar.
This template has four groups: Planning and design inputs, Design and development, Verification and validation, and Design transfer and release. It has 22 tasks and five milestones. "Write design and development plan" (3 working days) is the only starting task. "Capture user needs and intended use" (5) and "Open risk management file" (3) run side by side, and both must be finished before "Define design inputs" (6), so the inputs already reflect the first hazards. "Design inputs approved" is the first milestone.
The sequencing is the point. After the inputs gate, "Draft system architecture" (5) leads to "Develop hardware design" (15) and "Develop software design" (12). "Analyse design risks and update risk file" (6) starts 5 days into the hardware design and 4 days into the software design, so risk analysis follows the design as it takes shape instead of waiting for it. "Build prototype units" (8) waits for both designs, and "Design freeze review" waits for the prototypes and the risk update.
Verification and validation overlap where overlap is safe. "Write verification and validation protocols" (6) starts at "Design inputs approved", not at the freeze, because protocols are written against requirements. "Run design verification testing" (12) needs the freeze review and the protocols. "Fix failures and retest" (6) starts 8 days after testing starts, so fixes begin as findings appear. "Verification complete" waits for both. "Run usability and validation studies" (10) then waits for that milestone and the protocols, and "Review residual risk and benefit" (4) finishes 2 days after the studies finish, so "Design validated" is not reached until the risk file reflects the results.
Design transfer starts at "Verification complete", not at validation: "Transfer design to production" (8) and "Validate manufacturing process" (8) run beside the studies. "Compile design history file" (5) waits for "Design validated" and the process validation, and "Release decision" closes the plan. If a verification finding turns into a design change, the "Fix failures and retest" task is where that time goes. All durations are illustrative. A timeline schedules the work. It does not make a study, device, submission or system compliant, validated or approved. For related work, see /templates/new-product-introduction-gantt, /templates/capa-gantt-chart and /templates/medical-device-complaint-process. The same gate-and-sign-off logic runs through four neighbouring plans: /templates/clinical-trial-gantt-chart (a clinical study), /templates/regulatory-submission-gantt-chart (a regulatory submission), /templates/method-validation-gantt-chart (analytical method validation) and /templates/computer-system-validation-gantt-chart (computerised system validation).
What this flowchart covers
In this template
- Four groups, Planning and design inputs, Design and development, Verification and validation and Design transfer and release, with 22 tasks and five milestones: "Design inputs approved", "Design freeze review", "Verification complete", "Design validated" and "Release decision".
- A risk file kept in step with the design: "Open risk management file" feeds "Define design inputs", "Analyse design risks and update risk file" starts during the hardware and software design, and "Review residual risk and benefit" finishes 2 days after "Run usability and validation studies".
- Protocols written early: "Write verification and validation protocols" starts when "Design inputs approved" is reached and is needed by both "Run design verification testing" and "Run usability and validation studies".
- A verification loop: "Fix failures and retest" (6 days) starts 8 days after "Run design verification testing" starts, and "Verification complete" waits for both.
- Design transfer that does not wait for validation: "Transfer design to production" and "Validate manufacturing process" follow "Verification complete", then join "Compile design history file" with "Design validated".
When to use this template
- You are planning a new device or a significant design change and need to agree dates between design, quality, regulatory and manufacturing.
- You want to see how long verification and validation take if the first test round finds problems, not only if it passes.
- A launch or submission date is set and you want to compare the finish date with the date you need.
- You want a repeatable skeleton for design-control stages that each product can adapt.
The plan, task by task
Every task in the chart with its length in working days and what it waits for. A dependency is a step number; SS is start-to-start, FF is finish-to-finish, and +n is a lag in working days.
| # | Task | Group | Working days | Depends on |
|---|---|---|---|---|
| 1 | Write design and development plan | Planning and design inputs | 3 | |
| 2 | Capture user needs and intended use | Planning and design inputs | 5 | 1 |
| 3 | Open risk management file | Planning and design inputs | 3 | 1 |
| 4 | Define design inputs | Planning and design inputs | 6 | 2, 3 |
| 5 | Design inputs approved | Planning and design inputs | Milestone | 4 |
| 6 | Draft system architecture | Design and development | 5 | 5 |
| 7 | Develop hardware design | Design and development | 15 | 6 |
| 8 | Develop software design | Design and development | 12 | 6 |
| 9 | Analyse design risks and update risk file | Design and development | 6 | 7SS+5, 8SS+4 |
| 10 | Build prototype units | Design and development | 8 | 7, 8 |
| 11 | Design freeze review | Design and development | Milestone | 9, 10 |
| 12 | Write verification and validation protocols | Verification and validation | 6 | 5 |
| 13 | Run design verification testing | Verification and validation | 12 | 11, 12 |
| 14 | Fix failures and retest | Verification and validation | 6 | 13SS+8 |
| 15 | Verification complete | Verification and validation | Milestone | 13, 14 |
| 16 | Run usability and validation studies | Verification and validation | 10 | 12, 15 |
| 17 | Review residual risk and benefit | Verification and validation | 4 | 15, 16FF+2 |
| 18 | Design validated | Verification and validation | Milestone | 16, 17 |
| 19 | Transfer design to production | Design transfer and release | 8 | 15 |
| 20 | Validate manufacturing process | Design transfer and release | 8 | 19 |
| 21 | Compile design history file | Design transfer and release | 5 | 18, 20 |
| 22 | Release decision | Design transfer and release | Milestone | 21 |
How it works
Settle the inputs before the design starts
Keep "Capture user needs and intended use" and "Open risk management file" ahead of "Define design inputs". Replace the durations with how long your team really takes to agree inputs.
Keep the risk file moving with the design
"Analyse design risks and update risk file" is linked start-to-start to the hardware design with a lag of 5 days and to the software design with a lag of 4. Change the lags to match when your design has enough shape to analyse.
Write protocols against the inputs
"Write verification and validation protocols" starts at "Design inputs approved". Move it later if your protocols depend on a frozen design, and see what that does to the finish date.
Plan the retest, not only the test
Adjust the length of "Fix failures and retest" and its lag from "Run design verification testing" to reflect how often your tests find problems. A longer loop moves "Verification complete" and everything after it.
Decide how early transfer can begin
"Transfer design to production" waits for "Verification complete". Change that dependency if your design is stable enough to transfer earlier, or later if validation is likely to change the design.
Add owners, share and export
Put the responsible person in People, share the chart with design, quality, regulatory and manufacturing, and export a PDF or CSV when you need a copy for a review meeting.
Frequently asked questions
How long does medical device development take?
It depends on the device, its risk and your organisation. The template adds up to a few months of working days with illustrative lengths. Replace them with your own and read the finish date from the chart.
Does the chart make a device compliant or approved?
No. It schedules the work. Design control, risk management, testing and approvals follow your own quality system and the rules that apply to your product. The chart shows when each part is meant to happen.
Why are design reviews milestones?
A review is a decision point with no working time of its own. "Design freeze review" is a milestone so that later tasks visibly wait for it. If your reviews need preparation time, add a task before the milestone.
Can I show several verification rounds?
Yes. Add another "Fix failures and retest" task after the first and link it before "Verification complete". For the dependency types used here, see /guides/gantt-chart-dependencies and /guides/gantt-chart-overlapping-tasks.
What if the design changes during validation?
Add the change as tasks and link them back to the work they affect. For the change process itself, see /templates/change-management-gantt, and for the quality-system side see /templates/qms-implementation-gantt.