LOS ANGELES, Calif., October 1, 2024 - CovarsaDx, a prominent Clinical Research Organization (CRO) renowned for its expertise in vitro diagnostics (IVDs) and medical devices, is proud to announce its membership in the Medical Device Innovation Consortium (MDIC). This partnership marks a significant milestone in CovarsaDx’s ongoing mission to advance innovation in healthcare technology by providing reliable clinical validation results from an elite network of experienced investigators. 

The MDIC is a public-private partnership focused on advancing the regulatory science of medical devices. Bringing together stakeholders from industry, government, patients, payers, and healthcare providers, MDIC leads efforts to develop new tools, standards, and approaches to medical device design, manufacturing, and clinical integration. 

“We are excited to join the MDIC and be part of a collaborative ecosystem that drives progress in the medical device sector,” said Chermaen Lindberg, president and CEO of CovarsaDx. “MDIC provides unparalleled opportunities for sharing knowledge and resources across the industry, which directly aligns with our commitment to pioneering healthcare solutions. We’re eager to contribute our expertise in clinical trials and regulatory strategies to the consortium while learning from others who share our passion for improving patient outcomes.” 

As part of its MDIC membership, CovarsaDx will be contributing to three of the consortium’s key initiative groups: the Clinical Diagnostics Program, the Case for Quality Collaborative Community, and the Early Feasibility Studies Program. All these initiatives are at the forefront of shaping the future of medical devices and diagnostics, driving quality and innovation across the industry. 

The Clinical Diagnostics Program provides a platform for CovarsaDx to work alongside industry leaders and regulators to streamline the development of diagnostic tests and technologies. By participating, the company aims to contribute to the development of tools and frameworks that accelerate the clinical utility of diagnostic devices.  

CovarsaDx’s involvement in the Case for Quality Collaborative Community aims to help shape and elevate industry standards to enhance the quality of medical devices. This initiative emphasizes patient safety, product durability, and process efficiency, helping the industry adopt best practices that improve the entire lifecycle of medical devices, from development to post-market performance. 
 
Through the Early Feasibility Studies Program, CovarsaDx plans to collaborate on efforts to accelerate the development and implementation of innovative medical technologies during the development process, before starting a larger clinical trial. This program focuses on creating pathways for early-stage clinical evaluations, allowing breakthrough medical devices to reach patients more quickly and safely. 

“Our participation in these initiatives is a reflection of our deep commitment to improving patient outcomes and advancing healthcare technologies,” said Marielle Lejcher, vice president of regulatory affairs and quality at CovarsaDx and member of the executive steering committee for MDIC’s Clinical Diagnostics Program. “By collaborating with industry leaders and regulatory bodies, we’re able to contribute to the development of more effective diagnostic tools and uphold the highest standards of quality in medical devices. We’re excited to help drive these initiatives forward and bring meaningful advancements to the healthcare sector.” 

By joining MDIC and engaging in these initiatives, CovarsaDx not only strengthens its leadership in clinical research and regulatory expertise but also helps drive systemic improvements across the industry. 

About CovarsaDx 

CovarsaDx is a leading clinical research organization specializing in in vitro diagnostics (IVDs) and medical devices. The company provides agile responses to patient population needs and fluctuations in regulatory requirements for rapid market pathways. Their team of regulatory, quality and clinical experts have extensive industry experience and consist of regulatory strategists, quality experts, study managers, monitors, data managers, and statisticians who work together to deliver reliable clinical results. 

Contacts  

Media: media@covarsadx.com 

Study Inquiries: studies@covarsadx.com