If you have already concluded that a generic or pharma-built EDC is the wrong tool for a medical device investigation, this guide is for the next step: running the evaluation, structuring the vendor conversations, and building the internal case for the system you want.
If you are still working through why pharma EDC platforms create problems for device teams, our EDC systems guide for medical device manufacturers covers that ground first. When you are ready to evaluate vendors, come back here.
General EDC evaluation checklists are written for pharmaceutical buyers. The criteria below are specific to device investigations and will surface the gap between a pharma-adapted platform and one built natively for ISO 14155.
The system should arrive with complete validation documentation covering ISO 14155:2020 requirements. This is not the same as claiming compliance. Ask every vendor to show you the actual validation package in the first call. A purpose-built device EDC will have it ready. A pharma platform adapted for devices will ask you to scope a custom validation engagement, which means your team absorbs that cost and timeline.
Pass signal: vendor produces a complete IQ/OQ/PQ package covering ISO 14155 on request, at no additional cost.
Red flag: vendor says validation documentation is available as a paid add-on, requires a project scoping call, or is described as something you build together.
Device studies require per-procedure visit structures, device deficiency fields linked directly to adverse event reporting, and device identification data capture. These are not configuration options on a pharma platform. They are structural requirements that a pharma eCRF template will not accommodate without significant custom build.
Ask vendors to show you an eCRF built for a device investigation, not a generic demo. The difference will be visible immediately. See our eCRF completion guidelines and eCRF design guide for device studies for what good looks like.
Pass signal: vendor shows a device study eCRF with native device deficiency reporting and per-procedure visit logic without custom configuration.
Red flag: vendor shows a generic study template and describes device-specific fields as a configuration engagement.
Device protocols change mid-study more often than pharma protocols. The EDC needs to handle this without triggering a full re-validation cycle. Ask specifically: if we add an endpoint or change a visit structure two months into enrollment, what does that process look like and how long does it take?
Pass signal: vendor describes a workflow your clinical team can manage, with a clear process for documenting the amendment without stopping enrollment.
Red flag: any answer involving IT tickets, implementation sprints, or a new validation cycle for field-level changes.
ISO 14155 places oversight responsibility with the sponsor. That responsibility is difficult to fulfill if your access to study data depends on a CRO producing a report. The platform should give you live visibility into query status, protocol deviations, site performance, and data completeness directly from your sponsor account, as data is entered.
Ask vendors to show you the sponsor monitoring dashboard and explain how access is separated from CRO access. This should not require configuration or a premium tier.
Pass signal: sponsor account has live monitoring views that are structurally separated from site-level and CRO access, available in the standard offering.
Red flag: real-time access is described as an enterprise feature, or monitoring is described as something your CRO manages on your behalf.
You should be able to export your complete dataset in any standard format, at any point in the study, at no additional cost. Ask every vendor this question directly before you see a contract: what happens to my data if we end the relationship mid-study? If the answer involves fees, a waiting period, a proprietary format, or CRO intermediation, that is a lock-in risk worth quantifying before you sign.
Pass signal: vendor confirms in writing that full dataset export is available to the sponsor at any time in standard formats (CSV, SAS, SPSS) at no additional cost.
Red flag: data export provisions in the contract reference the CRO, require additional fees, or restrict format options.
For lean device teams without dedicated clinical ops staff, implementation time is a real constraint. A purpose-built device EDC should be able to get your first study running in one to three weeks. Ask specifically: what does onboarding look like for a first study, who runs it, and what is your typical time from contract signature to first subject enrolled?
The answer should include clinical operations specialists running the onboarding, not implementation engineers who need you to explain what ISO 14155 requires.
Pass signal: vendor references specific timelines from recent comparable studies and names the clinical background of the onboarding team.
Red flag: implementation is described as a project with a project manager, a scoping phase, and a timeline measured in months.
Under EU MDR, PMCF obligations do not end at market clearance. If your EDC cannot support PMCF surveys, registries, and long-term follow-up from the same interface where you ran your pre-market investigation, you will build clinical data fragmentation into your program from the start.
Pass signal: vendor shows a live PMCF study alongside a pre-market investigation in the same platform, with no mode switching or separate license required.
Red flag: PMCF is described as a separate module, a separate product, or something typically handled by a different tool.
Use these in evaluation calls. The pass/fail signals above give you the frame. These questions get you the specific answers.
On compliance and validation:
On eCRF design and study setup:
On data access and ownership:
On long-term fit:
Vendor evaluation is the easy part. Getting budget approved when your organization has existing EDC contracts, a CRO relationship that includes EDC, or a finance team that does not understand why clinical software matters requires a different kind of work.
Start with a cost-of-status-quo calculation. Pull real numbers from your last study:
Those numbers are your baseline. A pharma EDC that costs less per study license can easily cost more in total once you account for configuration, custom validation, data management overhead, and any lock-in on your own dataset. Loop Medical, a Class II device company that had been managing international studies on paper, set up a new study in a couple of weeks without working on it full time. In their words, real-time data access removed headaches from data collection and saved both time and money.
Frame the ask around risk, not software. The people approving this decision are not evaluating EDC platforms. They are evaluating whether the current approach creates regulatory, timeline, or data integrity risk. Your job is to make that risk visible and quantifiable. Compliance gaps that surface at a notified body review or an FDA inspection are not abstract. They have documented remediation costs. Use them.
Build a transition plan before the approval conversation. Your stakeholders will want to know: what happens to our current studies, how long does migration or parallel running take, and what does the vendor provide to support it. A purpose-built device EDC should help you build this plan as part of the sales process. If a vendor cannot give you a clear transition framework before you sign, that is a signal about what post-signature support will look like.
Run a structured evaluation across at least two vendors. Most organizations require documented vendor evaluation before approving a significant software purchase. Use the question bank above to score vendors consistently. The right MedTech EDC will distinguish itself quickly on validation documentation readiness, ISO 14155 compliance depth, and study setup time. Document the scoring. It makes the approval conversation faster and gives you a defensible paper trail if the decision is ever revisited.
Greenlight Guru Clinical is an EDC built specifically for medical device clinical investigations. It covers the full investigation lifecycle from a single platform: pre-market studies, PMCF surveys and registries, and long-term follow-up. ISO 14155 and 21 CFR Part 11 validation documentation is included. Sponsor monitoring access is direct and real-time. Dataset export is unconditional. Onboarding is run by clinical operations specialists. Most teams go from contract to first subject enrolled in under three weeks.
Get a demo of Greenlight Guru Clinical and bring your study design. We will show you how it runs on the platform.