Paris, October 07, 2024 – Eclevar MedTech, a leading european contract research organization (CRO) specializing in medical devices, proudly announces its colleboration with GENTELL (US manufacturer of medical device) to provide consulting expertise in clinical evaluation and post-market clinical follow-up (PMCF) strategies in wound care dressings and related products. This partnership marks a crucial step in the collaboration between the two companies, aiming to enhance innovation and make products of GENTELL compliant to the european requirement of the MDR 745/2017.
David Navazio, CEO of GENTELL, commented:
“We selected ECLEVAR MedTech for their proven expertise and comprehensive approach to regulatory requirements. Their team’s knowledge will help us ensure our products’ compliance while allowing us to remain focused on our mission of delivering innovative solutions to healthcare professionals.”
ECLEVAR MedTech, founded in Paris in 2018, has rapidly established itself as a trusted partner for medical device companies through its integrated approach to clinical trials, spanning the pre-commercialization phases to post-market clinical follow-up (PMCF). What sets ECLEVAR apart is its ability to design and implement tailor-made clinical solutions, supported by a global team of experts, helping companies navigate the often-complex regulatory environment with ease.
Through its innovative use of technology, ECLEVAR MedTech also offers enhanced clinical study management capabilities via its proprietary MILO Studio platform. This cutting-edge platform ensures that all clinical studies are conducted efficiently and with maximum flexibility, enabling seamless global management from start to finish.
HACHANI Chems, CEO of ECLEVAR MedTech, added:
“We are thrilled to collaborate with GENTELL, a renowned company in the wound care sector. At ECLEVAR MedTech, we are committed to delivering customized regulatory solutions, and this partnership highlights our ability to support clients throughout the entire clinical trial process. Our integrated approach and advanced technologies ensure that our partners can stay ahead of regulatory challenges while focusing on their core innovations.”
This partnership between GENTELL and ECLEVAR MedTech is expected to accelerate the regulatory approval of GENTELL’s medical devices while reinforcing their competitive edge in the European market.
GENTELL is a leader in the design and production of advanced wound care solutions. The company is dedicated to improving patient outcomes and meeting the needs of healthcare professionals with innovative products.
Eclevar MedTech, located in Paris, has quickly established itself since its founding in 2018 thanks to its integrated approach to clinical trials, from pre-commercialization phases to post-market clinical follow-up (PMCF). Eclevar stands out for its ability to provide tech-enabled service tailored medtech industry to overcome clinical challenges related to the MDR 2017/745, leveraging an international team of experts, clinical trial platform that speeds site feasability and qualification, patients identification as well as state of the Art eCOA/ePRO platform. ECLEVAR MEDTECH is backed by healthtech financial capital such as keles and ballas invest. https://keles.care/
Eclevar designs and conducts innovative and efficient clinical studies by leveraging cutting-edge technologies while ensuring flexibility through its MILO Studio platform. This approach ensures seamless global clinical study management, a particularly relevant asset for partners like GENTELL.
Press Contacts:
GENTELL
Marketing and Communications Department
Email: info@gentell.com
Website: www.gentell.com
Eclevar MedTech
Public Relations Service
Email: Clientcare@eclevar.com
Website: www.eclevarmedtech.com
About GENTELL:
GENTELL is a U.S.-based leader in advanced wound care solutions, dedicated to providing innovative products and services that improve the quality of care for patients with chronic and acute wounds. The company offers a wide range of wound dressings, therapeutic devices, and skin care products designed to promote healing and prevent complications. GENTELL’s commitment to quality and innovation ensures its products meet rigorous safety and efficacy standards, supporting healthcare professionals in delivering optimal patient outcomes. With a strong presence in the U.S. and international markets, GENTELL continues to expand its footprint in the field of wound care.
About Eclevar MedTech:
Eclevar MedTech is a Paris-based contract research organization (CRO) providing comprehensive services for clinical trials and regulatory compliance in the medical device and in vitro diagnostics sectors. The company specializes in designing and conducting innovative clinical studies using advanced technologies, supported by its flexible MILO Studio platform. Eclevar MedTech’s expertise helps streamline clinical evaluation and post-market surveillance processes, ensuring efficient and compliant product development.
Company identification : Eclevar Medtech UK LTD, 15964075, 124-128 City Road, London, England, EC1V 2NX