For manufacturers with more than one product. Buy lines of reserved testing capacity, run any product on them at will, and cover premarket submissions and postmarket annuals under one agreement. No SOW per test, no scheduling calls.
Legacy testing contracts are created for a single test on a single product, and everything in them assumes the date you picked months ago will hold. It rarely does.
The vendor commits to a window you chose months earlier. When the build slips, the window is gone and the tester is on another job, and a moved date becomes a negotiation, sometimes with a fee attached.
Contracting, legal review, PO, kickoff, startup, delivery, close. The cycle repeats for every product, every version, and every retest. A portfolio of 20 products is 20 of everything.
Each contract starts with a blank scope and a new team. Prior test cases live in a PDF somewhere, and the tester re-learns your product on your clock.
ELTON ONE solves the paperwork for one product. ELTON ENTERPRISE solves it for a portfolio, and adds the capacity guarantee.
| Legacy per-product SOW | ELTON ONE | ELTON ENTERPRISE | |
|---|---|---|---|
| Term | One test | 12-month subscription | Annual term, priced by line |
| Products | One product, one version | One product, one commercial release | Any product, changed at will, unlimited across the term |
| Capacity | Whatever is free that week | Managed service for that product | Reserved, 100% for the lines you contract |
| Paperwork per test | Full SOW, PO, kickoff | None after signature | One order form per product |
| Startup | Every time | Once, at onboarding | Once per product, then kept current |
| Best for | A one-off test with a fixed date | A manufacturer with one product | Any manufacturer with more than one product |
One line tests one product at a time. When that product finishes, the next starts. The line is yours for the whole term, whether or not something is on it.
Capacity is fully reserved for every enterprise customer, for the whole term. An urgent need starts immediately if the line is open, because there is no scheduling question left to ask. Gaps are expected, and the line waits.
Each product and test type carries an SLA. Premarket regulatory tests and postmarket annuals run on different SLAs, and when one test completes the next product on the schedule begins. A retest or a mitigation check slots into downtime.
Every product gets a short scoping meeting and a demo, then you agree on the SKU. That is the whole commercial conversation.
Web, mobile, local or desktop applications, and the cloud services and APIs behind them.
Implantable, OR and surgical, bedside and patient-connected. Any form factor, any interface.
A physical device plus its applications, or a device plus other connectivity, tested as one system. Dataflows across the boundary are in scope.
No separate contract. One ELTON Platform Service Order Form per product, then the same process every time.
Product, services, scope, access, dates, contacts, materials, rules of engagement, sign-off.
A short meeting and a product demo, then the SKU and modifier are agreed.
Materials, target provisioning, access, validation, and the test plan.
Runs on the line under the SKU's SLA.
Draft findings, your questions, then final findings.
Accepted remotely, or a walkthrough on request.
Capacity is allocated in advance, so the price carries none of the start, stop and re-contracting expense that per-product pricing has to absorb, and the tester never re-learns your product.
Capacity is reserved and priced once for the term. Onboarding happens once per product, then is kept current. Later releases test the diff against the retained record. There is no scheduling premium, no expedite fee, and no prioritization fee. Per product, it is significantly cheaper than a single-product contract, because none of that overhead is in the number.
Enterprise customers meet with us at least weekly, so prerequisites for the next product are done before a line opens. Each product is onboarded once and every prior test case is retained. A new release tests only the change, with no new vendor and no re-learning, so what used to take weeks can take a day or two.
Most manufacturers stall on funding, because products sit in different business units with different budgets. Two contract shapes solve that.
One enterprise contract per business unit, right-sized to that BU's products and release calendar. Simplest to approve and simplest to renew. Recommended when BUs budget and buy independently.
One contract, funded by cost sharing across BUs, invoiced on actual utilization. A shared line pool absorbs one BU's slow quarter with another's busy one. Recommended when a central product security team owns the budget.
The premarket guidance expects testing throughout development and at regular intervals after release. Reserved capacity is the contracting vehicle that makes that affordable across a portfolio.
"FDA recommends that cybersecurity testing should occur throughout the SPDF. Security testing early in development can ensure that security issues are addressed prior to impacting release timelines. After release, cybersecurity testing should be performed at regular intervals commensurate with the risk (e.g., annually)."
"Cybersecurity risks may continue to be identified throughout the device's TPLC. Manufacturers should ensure they have appropriate resources to identify, assess, and mitigate cybersecurity vulnerabilities as they are identified throughout the supported device lifecycle."
The deciding question is product count. If you have two products you already have the scheduling problem, and reserved capacity is how it comes off your desk.