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.
Head of Clinical operation
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.
EX MHRA – Deputy Director of Innovative Devices
Eclevar UK VP clinical and regulatory at ECLEVAR UK
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.
Head of Clinical Evaluation
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.
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
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.
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:
MDCG Guidance documents summary series: MDCG 2020-10/1 – Safety reporting in clinical investigation of medical devices under the Regulation (EU) 2017/745 and it’s Appendix MDCG
UKCA Mark & Alternative routes to market – a risk or an important step towards global regulation? Next under the spotlight of this series is
MDCG 2021-28 – Substantial modification of clinical investigation under Medical Device Regulation Introduction As per MDR 2017/745 Art. 75 Substantial modifications to clinical investigations, and
Equivalence in Great Britain – How to use it! Different regulatory jurisdictions utilise ‘equivalence’ in different ways, from forming part of a clinical evaluation to
ECLEVAR FRANCE:
Tour Europlaza
20 avenue André Prothin
92 827 Paris La Défense Cedex
France
ECLEVAR UK Limited:
3rd Floor 207 Regent Street, London, W1B 3HH
ECLEVAR GMBH
ERFURT, Erfurt Hauptbahnhof
4th, 5th floor
Bahnhofstr. 38 Erfurt
99084
ECLEVAR Australia
Umina Beach NSW 2257, Australia
