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Eclevar Australia

About us

ECLEVAR MEDTECH is a global CRO, headquartered in France. We support medical device and IVD manufacturers with the transition to the EU MDR and IVDR by offering following services: clinical evaluation, premarket clinical trials, Post-Market Clinical Follow- up (PMCF) studies, collection of real-life data (RWD) and use of real-world evidence (RWE) to support regulatory submissions.

Our team

We have offices in Europe, UK, and Australia, which allows us to conduct
international multi-site clinical trials, while providing local support.

Val Theisz, MSc RAC is Eclevar Australia’s VP Clinical & Regulatory Affairs.

Val Theisz has been Principal Consultant, Co-founder and non-executive Director, Certification Body Australia

Val is a regulatory affairs professional with over 15 years of experience in medical devices of all risk classes, including life-sustaining, high-risk active implantables, and software as medical devices (SaMD) using Artificial Intelligence (AI) algorithms. Val has a Masters degree in electrical engineering and holds Regulatory Affairs Certification credentials for EU and US regulations (RAC EU, RAC US) from the US- based Regulatory Affairs Professionals Society (RAPS).

Val’s experience within the field covers clinical trials for high-risk innovative medical devices; submissions and pre-market approvals in established markets (CE Marking, FDA 510(k) and PMA, TGA registration). Val has also been the Director of Regulatory & Clinical Affairs, Code of Practice with the Medical Technology Association of Australia (MTAA), leading industry advocacy initiatives with the Therapeutic Goods Administration and the Australian Department of Health. 

Strategy

Analysis

Solutions

We provide a customizable market access approach in both global and local markets.

We can help you determine what evidence you need to gather in order to have a successfully launch of your product.

Market access strategies

Clinical evaluation report

First inhuman clinical trials

Survey

Registries

Observational study

Technical documentation Reviews

QMS

We are available to discuss your needs
and help your product to achieve market access.