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.

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ECLEVAR MEDTECH is a global medical device CRO, headquartered in Paris. We support medical device manufacturer in the MDR and IVDR transition.

FLORENCE LONGUEVILLE

Head of Clinical operation

PMCF Expertise from Industry perspective: 

For nearly 25 years, global lead and international postmarked clinical follow-up (PMCF) projects within multicultural teams such us Terumo Aortic. Support of medical device companies on the challenges hold by clinical operations while implementation of the MDR 2017: 745.

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ECLEVAR MEDTECH is a global medical device CRO, headquartered in Paris. We support medical device manufacturer in the MDR and IVDR transition.

Dr. Camilla Fleetcroft

EX MHRA – Deputy Director of Innovative Devices

Eclevar UK VP clinical and regulatory at ECLEVAR UK

Premarket and PMCF Expertise from Competent authority and Notified body : 

Former head of MHRA for over 10 years and the SGS. In her role, as Deputy Director for Innovative Devices, she led the development of the future UK regulations for medical devices following Brexit. Prior to that Camilla was the Head of Clinical Investigations and Clinical Evaluation at MHRA and before the UK exit from the EU, she represented the MHRA in the EU Clinical Investigations and Clinical Evaluation working group, leading the drafting for MDCG 2020-05 on Equivalence.

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ECLEVAR MEDTECH is a global medical device CRO, headquartered in Paris. We support medical device manufacturer in the MDR and IVDR transition.

Burhan Mehmedi

Head of Clinical Evaluation

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.

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ECLEVAR MEDTECH is a global medical device CRO, headquartered in Paris. We support medical device manufacturer in the MDR and IVDR transition.

Pr.Yann Goueffic

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

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ECLEVAR MEDTECH is a global medical device CRO, headquartered in Paris. We support medical device manufacturer in the MDR and IVDR transition.

LAURA BENNICHE

Data protection Officer/French Ethical committee member

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). 

 

LAURA Benniche is member of the French Ethical committee and specialize in clinical data protection to ensure complete compliance of your study with GDPR.  

 

ECLEVAR MEDTECH conduct full PMCF activity in Europe, UK and Australia.

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

Coming soon 

PMCF Activites

Coming soon 

Traditional clinical trials

Coming soon

RWE generation

Coming soon

Observational studies

Coming soon

Registries

Coming soon

Patient surveys

Coming soon

Prospective

Coming soon

Retroprospective

Coming soon

Hybrid trial

Coming soon

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

Coming soon 

PMCF Plan

Coming soon 

PMCF Activites

Coming soon 

Traditional clinical trials

Coming soon

RWE generation

Coming soon

Observational studies

Coming soon

Registries

Coming soon

Patient surveys

Coming soon

Prospective

Coming soon

Retroprospective

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 ASSOCIATION

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

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