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 ![Greenlight Guru Clinical](https://images.g2crowd.com/uploads/product/image/large_detail/large_detail_bb00457256f68ccf121d0b0700f4f29f/greenlight-guru-clinical.png "Greenlight Guru Clinical")
 
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# Greenlight Guru Clinical Discussions

Greenlight Guru Clinical is the only electronic data capture (EDC) platform built specifically for medical device and diagnostic companies. While most EDC tools were designed for pharmaceutical trials and later adapted for medtech, Greenlight Guru Clinical starts where device teams actually work: under FDA, EU MDR, IVDR, and ISO 14155:2020 requirements, running studies that need to generate reliable clinical evidence for regulatory submissions and post-market obligations. The result is a platform that fits how device teams actually operate, rather than one they have to work around. Clinical teams use Greenlight Guru Clinical to design, run, and close studies on a single validated system. Electronic case report forms (eCRF) can be built in minutes using pre-validated question types, then cloned and reused across studies to reduce setup time. Patient-reported outcomes (ePRO/eCOA) are collected in-person or remotely on any device. eConsent, randomization (RTSM), post-market clinical follow-up (PMCF) surveys, and adverse event reporting are all managed within the same platform, so teams are not stitching together multiple tools to cover a single study. Built-in GCP compliance means audit trails, Part 11-compliant e-signatures, and ISO 14155:2020-aligned workflows come standard. Data is submission-ready by design, not as an afterthought. A two-way open API supports integration with third-party systems for teams that need data to move across platforms quickly and securely. Where Greenlight Guru Clinical stands apart from general-purpose EDC vendors is in the support model. Every customer gets a dedicated customer success manager with real medtech experience, not a generalist account rep. Onboarding is structured to get teams up and running fast, and a validation package is included with every product update, removing the ongoing burden of software revalidation that typically falls on the quality team. Greenlight Guru Clinical is used by medical device manufacturers running pre-market clinical investigations, post-market clinical follow-up studies, PMCF surveys, registries, and human factors testing. It is also widely used by contract research organizations (CROs) that specialize in medtech and need a platform that speaks their clients' regulatory language without requiring extensive customization. For teams that also use Greenlight Guru's quality management system, Clinical integrates directly into a connected platform covering quality, product development, and clinical evidence in one place. For teams that don't, it works as a fully standalone EDC solution. If your team is running medical device studies and spending too much time adapting pharma-built software to fit your regulatory context, Greenlight Guru Clinical was built for exactly that problem.

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