The medical device development process is Phase 0–5: clinical need → business plan → design and prototype → verification and validation → final design and clearance → launch and post-market surveillance. It is how a device is built. It is not the 510(k) tree, not the QMS how-to, and not the launch plan.
If you meant FDA 510(k) / PMA / De Novo → FDA medical device approval process. If you meant QMS / ISO 13485 → medical device quality management system. If you meant ISO 14971 risk → medical device risk management. If you meant PMS → medical device post-market surveillance. If you meant GTM / reimbursement → medical device go-to-market strategy. If you meant IQ / OQ / PQ → medical device validation process. If you meant design V&V → medical device verification and validation. If you meant device software → medical device software development.
If the device is imaging software, PYCAD is the imaging stack (viewer / model), not the regulatory agent / QMS vendor / GTM shop.
Phase 0–5
| Phase | Job | What leaves the room |
|---|---|---|
| 0 — Clinical need | Unmet need, who has it, why current tools fail | Need statement and target product profile |
| 1 — Business plan | IP, money, first cut of the regulatory path | Go / no-go and a written pathway |
| 2 — Design, prototype, test | Feasibility hardware or software, usability, bench | A device you can hold or run |
| 3 — Verification and validation | Built to spec, and the right device for the user | V&V evidence. How-to is design V&V |
| 4 — Final design and pre-launch | Lock the design. File. Get clearance or approval | Letter from FDA. Pathway itself is 698 |
| 5 — Launch and PMS | Ship, watch the field, feed the file | Complaint / PMCF loop. How-to is PMS |
Phases overlap. Regulatory work starts in Phase 1, not the week before the file. Design controls (21 CFR 820.30) sit under the whole spine — inputs, outputs, reviews, changes — so a late change has a trail. The QMS that holds those records is ISO 13485 / 21 CFR 820.
Phase 0–1: a real need, then a plan
Most dead devices solved a problem nobody had, or a problem too small to pay for. Talk to the clinician, the patient, and the payer before you freeze a concept. A diabetes gadget that patients will not wear is not a need; it is a sketch.
Validate the concept with structured feedback — simulated use, a short interview protocol — not a hallway nod. Protect IP while you still talk. Early prototypes are proofs, not products: one function, cheap to throw away, built to learn.
Phase 1 is the go / no-go. Cost to make, who else is on the shelf, what you can patent, and which class the device is likely to sit in. Class is not this page’s job; it picks the file on FDA medical device approval process. Write the path here so Phase 2 does not design a Class III device on a Class II budget.
Phase 2: design and a prototype you can test
Cross-functional from here: engineering, clinical, quality, whoever will sell it. Design inputs come from the need statement. Design outputs are drawings, code, and process specs. Reviews catch the clash between “easy for the surgeon” and “makeable at the quoted cost.”
Uncontrolled change is how timelines die. Propose, impact, approve, version. Design verification and validation in Phase 3 check the locked design; they do not invent it. If software is the device, the lifecycle is medical device software development — IEC 62304 lives there, not as a costume on this page.
Phase 3–4: prove it, then file
Verification: outputs match inputs. Validation: users can use it for the intended use. That pair, the V-model, and the Design History File are device verification and validation. Process validation (IQ / OQ / PQ) is the validation process page. Risk work that feeds both is ISO 14971.
Phase 4 locks the design and takes the file to FDA (or the Notified Body). Pre-subs, predicates, PMA clinical bars — that is the regulatory maze, and it has its own URL. This page only needs the rule: do not start the file from a Phase 4 surprise. The class you picked in Phase 1 is still the class.
Phase 5: launch is not the end
Shipping starts post-market surveillance, not a party. Complaints, PMCF, and the living risk file feed the next revision. How to run that loop is PMS. How to get paid and adopted is GTM.
FAQ
Where does FDA classification sit in this process?
In Phase 1 you pick a likely class so the test plan matches the file. The class → 510(k) / De Novo / PMA tree is FDA medical device approval process.
Is this the same as design controls?
Design controls are the method inside Phases 2–4. The process page is the lifecycle. The QMS page is the system that stores the records.
Does PYCAD develop medical devices?
No. If the device is imaging software, PYCAD is the imaging stack (viewer / model), not the manufacturer of record and not the regulatory agent. Case studies.