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How to avoid the Nobified Body CER's rejections - Eclevar's webinar series

PMCF PRESENTATION

Navigating the Reimbursement Process in EU

Overview of routes to reimbursement in the EU and particularly France

It takes curiosity and intellectual courage to accomplish great things. It takes brave minds to bring powerful ideas to reality and transform healthcare. We are a global team with diverse culture where women and men are equals and shares a passion for collaboration and solving complex problems. Together, we help customers drive healthcare forward.

ISO 14155 2020 SIV Contents to train Sites 20220713 132402 Meeting Recording

Interdisciplinary team set-up Survey based on Classification of Device: Difference between Marketing Surveys, Clinical Surveys, Subject Surveys Retro- or prospective Data collection, Question of validation of survey Investigator’s perspective

Under the Medical Device Directives (MDD), Post market clinical follow-up (PMCF) is mentioned only three times, twice in Annex II EC Declaration of Conformity (Full quality assurance system), section 5 Surveillance, and once in Annex X Clinical Evaluation, section 1 General provisions. The MDD does not define PMCF, only states that it is part of the post-market surveillance, and where it is not...

The key changes under the MDR in relation to the PMCF are: Strengthening of PMCF requirements by including specific requirements for PMCF in the text of the regulation instead of leaving them in a guidance document Specifying the required elements of the PMCF plan Including a requirement for specifying the methods and procedures of clinical data collection Stating the objectives of the PMCF

The main objective of any clinical evaluation is to demonstrate the safety and performance of a medical device. This is an essential process that is part of the conformity assessment procedure for obtaining the CE mark. In the MDR, the scope and emphasis of the clinical evaluation is more important than in the MDD. Eclevar, a CRO specialized in medical devices, hosts a 45-minute webinar dedicat...

CRO Culture: Wherever ECLEVAR MEDTECH does business in the world, the fundamental values of honesty, integrity and ethical conduct form the core of everything we do. Our reputation is shaped by the personal decisions of every employee. Our staff strive to be decent and fair-minded, and do what is right on the job, even in the most difficult situations. Our Code of Conduct, Doing the Right Thing...

A medical device CRO or In-Vitro Diagnostic Devices (IVD) CRO is a contract research organization (CRO) that provides support to medical device and In-Vitro Diagnostic industries in the form of research services outsourced on a contract basis. A CRO provide services as biologic assay development, commercialization, clinical development, clinical trials management, and Real world evidence. CROs ...

What is clinical evaluation report ? A clinical evaluation report (CER) is part of the technical documentation and is intended to describe the medical devices under evaluation, and plan literature searches and any clinical and/or biomechanical studies to obtain all pertinent information to demonstrate whether the medical device in scope conforms with the applicable General Safety and Performanc...

Clinical Developement Capabilites