ECLEVAR MEDTECH is a unique CRO, it brings Competent Authority, notified body, industry and CRO expertise together to overcome your clinical evaluation (CER) , clinical trials and regulatory challenges.
Burhan Mehmedi Principal clinical project manager, Germany | Clinical Evaluation Report Expertise :More than 14 years of medical writing expertise at Namsa. Since 2012, authored and co-authored more than 130 clinical evaluation reports (CERs) for all class medical devices (class I, IIa/IIb and III) according to the MEDDEV 2.7.1 Rev. 3 (2009) and MEDDEV 2.7/1 Rev. 4 (2016), MDD, EU Medical Device Regulation (MDR) 2017/745 and In-Vitro Medical Device Regulation (IVDR) 2017/746. |
Pr.Yann Goueffic MEDICAL EXPERT REFERENT VASCULAR SURGEON | Scientific board member at ECLEVAR, referent endovascular and open procedures for peripheral arterial diseases-Professor of vascular surgery in the Vascular Center at Groupe Saint Joseph, Paris. -President of Clinical trial Unit at Groupe Hospitalier Paris Saint Joseph |
LAURA BENNICHE Head of Quality affairs at ECLEVAR |
LAURA Benniche is member of the French Ethical committee and specialize in clinical data protection to ensure complete compliance of your study with GDPR.
Depending on the country you conduct your PMCF activity, whether you are putting in place registry or conducting observational study or simply a survey, the activity must comply to ISO 14155 and GDPR. The PMCF study will be conducted in compliance with GDPR and depending on the country, it follows a specific methodology (example in France and Germany).
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Stéphanie Bengochea Senior CRA | Senior CRA :
Registred nurse, with 6 year’s experience in clinical research in Cardiovascular and urology studies. |
Peter West Head of Quality affairs at ECLEVAR | Head of Quality affairs at ECLEVARPeter is responsible on maintaining the QMS system of ECLEVAR compliant to ISO 13485 and ISO 27001. With 20 years experience in QMS construction and improvement experience based against US FDA, EU MDR/CE and UK MDR/UKCA requirements using his IRCA Lead Auditor and Lean Six Sigma abilities to put ECLEVAR in next level. |
We work according to the following internationals standard
Competent authorities around the world exchanges information’s about your products risk and efficacy who put your business on stake. ECLEVAR MEDTECH can see your challenges from different angles for better support and understanding. From clinical reports to clinical data collection.
With an international team that encompass:
Eclevar Australia provides an update on Australian regulatory requirements for personalized including 3D printed medical devices – February 2023 TGA has updated its regulatory framework
Creating the Future in Clinical Research with CROs Using Real-World Data Tuesday, February 14, 2023, 9 am CT, 10 am ET, 3 pm GMT, 4
A shift to an international approach to safety and performance? Regulators across the globe know, only to well, the challenges posed by software as a
Eclevar Australia provides an update on TGA acceptance of overseas approvals for ARTG inclusion of medical devices – December 2022 TGA is currently accepting approvals
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