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Copie de Vascular medical device CRO with a strong capability for vascular clinical studies (1050 × 800 px) (2)
Copie de Vascular medical device CRO with a strong capability for vascular clinical studies (1050 × 800 px)
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22 MARCH, 2023 - Element's MedTech

Element’s MedTech Conference seeks to challenge the existing regulatory structures and discuss how medical technologies can be brought into play at the right time and within a framework that optimises time to market and delivers a higher degree of confidence

19/04/2023 - Medtech Japan

Medtec Japan is the most important technology event for the medical device manufacturing industry in Japan concerning manufacturing and automation technology, materials, and outsourcing.

04/04/2023 - Snitem Innovative medical device start-up day

The Snitem (National Union of the Medical Technology Industry) is organizing a competition open to medical device start-ups and aimed at highlighting 12 French innovations.

21/02/2023 - OCT - Outsourcing In Clinical Trials

The space to discuss the latest challenges in outsourcing and share innovations for all things Medical Device.

15/02/2023 - 8th ANNUAL EUROPEAN MEDICAL DEVICE CONFERENCE

The investigator-initiated study (IIS) is not a new concept in the MedTech industry. However, the processes and the compliance framework governing clinical studies have become far more complex due to significant changes.

MEDICAL DEVICE CRO FROM PREMARKET TO POST MARKET CLINICAL FOLLOW-UP (PMCF)

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.

We work according to the following internationals standard 

Peter West

Head of Quality affairs at ECLEVAR

George Das neves silva

Cyber security

LAURA BENNICHE

CLINICAL DATA PROTECTION OFFICER

Allan Onofre

IT infrastructure and network engineer

BALANCES REGULATORY, CLINICAL EVALUATION, AND BUSINESS RISKS AND OBJECTIVES

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.

Eclevar Medtech - eCRF - Our dedicated PMCF services
CER
Clinical Data Deficiencies

Coming soon 

PMCF Plan
PMCF Activites
Traditional clinical trials
RWE generation
Observational studies
Registries
Patient surveys
Prospective

Coming soon

Retroprospective

Coming soon

Hybrid trial

Coming soon

With an international team that encompass:

  • Former Competent Authority/notified body experts
  • Clinical Evaluation and PMCF experts from the industry 
  • Medical device CRO experts
  • Key opinions leader for better understanding of your products

ECLEVAR is part of the ecosystem you need to grow your business in Europe (France, Germany) and the UK. With ECLEVAR, you WILL overcome your regulatory challenges and non-conformity and ensure long-term clinical strategy that support your business.

If you want know more, Get In touch with OUR Global Chief commercial OFFICER:

EDMUND WHITE

Within 3 years, ECLEVAR delivered transformative solutions.

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OUR MEDICAL DEVICE PARTNERS AND ASSOCIATIONS

A Regulators Perspective on Clinical Evaluations and Investigations

  • A regulator’s thought on the new clinical evaluation requirements – does it solve the problem?
  • What are the key challenges for the regulator in implementing the new requirements?
  • The UK – a regulator with ‘two halves’. What are the implications for the UK, and what happens in 2023

Our latest pictures and video

LATEST NEWS

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