MedTech is not pharma: what an EDC built for device studies actually gives you

Every clinical study for a medical device runs under ISO 14155, and needs shift by device class, phase, and type, first-in-human, feasibility, pivotal, PMCF. Your eCRFs and workflows need to shift with them, without a custom build for every new study.

That holds at any scale. A manufacturer can run studies for a new product and a product already on the market on the same platform, and a CRO can grow its medtech practice from one sponsor to many, both without reconfiguring or rebuilding the setup each time.

Greenlight Guru Clinical is built this way, backed by 15+ years and 1,500+ device trials of medtech-specific experience. Join Pall Johannesson and Carl Taylor for a live look at how it works.

You will learn:

• What working within ISO 14155 requires from an EDC's eCRFs and workflows
• How to handle device study variability, feasibility through PMCF, without a custom build each time
• How manufacturers and CROs both scale study volume on the same platform without reconfiguration
• A look at study setup inside Greenlight Guru Clinical