Greenlight Guru and bioaccess® Partner to Accelerate Market Access and Improve Patient Outcomes in Latin America and Beyond
A Strategic Collaboration to Streamline Regulatory Navigation, Clinical Research, and Product Development for Medtech Companies
[MIAMI, FL, April 8, 2022] – Greenlight Guru and bioaccess® have joined forces to help medical device manufacturers bring innovative products to market faster, with less risk, and improved patient outcomes. This strategic partnership combines the industry’s leading Medtech-specific eQMS and EDC solutions with a dedicated contract research organization (CRO) and market access consulting firm, ensuring a seamless path from product development to commercialization.
Greenlight Guru Clinical is a modern, medical device-specific electronic data capture (EDC) solution designed to streamline clinical research. As part of Greenlight Guru’s MDSP, Greenlight Guru Clinical helps Medtech companies accelerate feasibility, pivotal, and post-market studies by simplifying study design, enhancing data collection, and ensuring regulatory compliance. With real-time collaboration tools, advanced analytics, and intuitive workflows, the platform enables sponsors, sites, and investigators to drive data-driven decision-making while reducing costs and time to market.
Greenlight Guru Quality provides a fully connected, industry-leading electronic quality management system (eQMS) that empowers medical device manufacturers to maintain compliance, improve efficiency, and ensure product quality. Built specifically for medtech companies, Greenlight Guru Quality centralizes document control, risk management, design controls, and post-market surveillance, helping teams proactively manage regulatory requirements and scale operations with confidence.
bioaccess® tackled another challenge in the industry: Foreign Medtech companies struggle to find an investigator for their early feasibility clinical studies and a way to sell their innovations in Latin America. These companies are unfamiliar with the region. They lack in-house experts to help operationalize a successful clinical, regulatory, or commercial market access strategy to ensure long-term success in Latin America. Since 2010, bioaccess® has provided clinical research and market access consulting services to foreign medical device manufacturers looking to succeed in Latin America with their first-in-human clinical trials and the commercialization of their innovations in the region.
Both Greenlight Guru and bioaccess® are disrupting an industry to provide solutions built specifically for the Medtech industry. The partnership presents Medtech companies with industry-specific out-of-the-box software solutions to automate quality, regulatory, and product development and industry-specific clinical research and market access solutions to ensure their long-term success in Latin America.
About Greenlight Guru
Greenlight Guru is the only purpose-built platform to give medical technology companies an end-to-end software solution to bring life-changing products to patients. The platform integrates cross-functional teams, processes, and data throughout the entire product lifecycle, giving visibility and traceability beyond compliance requirements to proactively overcome execution gaps and accelerate success. Thousands of Medtech professionals are using Greenlight Guru’s platform across the globe to push beyond baseline compliance and achieve True Quality for their medical devices. For more information, visit www.greenlight.guru.
About bioaccess™
bioaccess® is a US-based contract research organization (CRO) that delivers a full spectrum of clinical and regulatory service offerings so that foreign medical device companies can have long-term success in Latin America. For more information, visit www.bioaccessla.com.
Media contact
bioaccess®
Julio G. Martinez-Clark, +1 (954) 903-7210
Chief Executive Officer
jmclark@bioaccessla.com
Greenlight Guru
Naomi Gollmer (419) 518-0067
Content/PR Specialist
naomi.gollmer@greenlight.guru
