Eclevar

ABOUT ECLEVAR

ECLEVAR is a full service CRO dedicated for medical device manufacturers.

Our Benchmark is the unique combination of high level expertise and staff with field experience. All consultants had former positions at medical device manufacturers and European notified bodies 

Our mission is to assist medical device and in-vitro diagnostics manufacturers worldwide with medical device market access, clinic trials and achieving regulatory compliance.

OUR SERVICES

DEDICATED SOLUTIONS FOR MEDICAL DEVICES

Clinical Evaluation Report

Our CERs are co-written by medical writers and medical experts according to our MDR template

Clinical Trials

Full-Service CRO, and Post-Market Clinical Follow-up for Medical Devices

Technical File Consulting and Audit

Implement and maintain a Quality Management System (QMS) to ensure your medical device meets certain specifications and requirements.

PMS Audits and Consulting

Our regulatory experts are qualified from different notified bodies. They assist you in determinining regulatory compliance and improve the affectivity of you internal processes and those of your subcontractors and suppliers.

Clinical evidence options are available to manufacturers on a cost continuum. We offer custom support depending on your needs, urgency, and budget. Here are just few options

Once you have a compliant CER for your marketed device, updating it with data from surveillance or ongoing clinical programs is essential. We use different process that may help enrich your CER and optimize acceptance from Authorities...Read More

Are ECLEVAR’s services a good fit for your needs ?

Contact a ECLEVAR representative +33 1 45 01 61 60 or through our site contact form

ECLEVAR clinical team can review your CER looking for gaps against MDR.

The outcome of the gap analysis will determine the PMCF protocol to enrich your CER with the required clinical evidence.

Whether you require prospective or retrospective PMCF study, ECLEVAR is able to set up complaint PMCF study with MDR and ISO 14155..Read More

Are ECLEVAR’s services a good fit for your needs ?

Contact a ECLEVAR representative +33 1 45 01 61 60 or through our site contact form

Ensuring that CER writers/stakeholders are trained on the CER process and are not relying solely on guidance will remove the likelihood of time-consuming revisions after NB review.

Training courses are available on clinical evaluation...Read More

Are ECLEVAR’s services a good fit for your needs ?

Contact a ECLEVAR representative +33 1 45 01 61 60 or through our site contact form

THERAPEUTIC AREA

Our most therapeutic experience is in these five key areas :

ECLEVAR has extensive experience with Class II and Class III spinal devices, including spinal stabilization and fixation devices and disc and vertebral body replacement devices...Read More

 

Are ECLEVAR’s services a good fit for your needs ?

Contact a ECLEVAR representative +33 1 45 01 61 60 or through our site contact form

ECLEVAR has has extensive experience with Class II and Class III orthopedic, spinal and orthobiologic devices.

ECLEVAR projects have included large and small joint replacement devices, cartilage repair systems, spinal stabilization and fixation devices, disc and vertebral  body  replacement devices, and biologics including bone
morphogenic proteins (BMP), allografts and demineralized bone matrix  products...Read More

 

Are ECLEVAR’s services a good fit for your needs ?

Contact a ECLEVAR representative +33 1 45 01 61 60 or through our site contact form

ECLEVAR has extensive experience with Class II and Class III cardiac, cardiovascular, and neurovascular devices, such as ventricular assist devices, circulatory support, pacing devices, aneurysm stents and fillers, IVDs (cardiac markers), combination products and tissue/biologics...Read More

 

Are ECLEVAR’s services a good fit for your needs ?

Contact a ECLEVAR representative +33 1 45 01 61 60 or through our site contact form

ECLEVAR has extensive experience with Class II and Class III peripheral vascular devices and in offering the most cost efficient, timely contract research organization (CRO) services for these types of organizations...Read More

 

Are ECLEVAR’s services a good fit for your needs ?

Contact a ECLEVAR representative +33 1 45 01 61 60 or through our site contact form

ECLEVAR provides various clinical research organization (CRO) advanced imaging and video services such as:

Ultrasound Imaging
MRI (Magnetic Resonance Imaging)
Computed Tomography (CT)
Dental Cone-beam Computed Tomography
Fluoroscopy
Mammography

...Read More

Are ECLEVAR’s services a good fit for your needs ?

Contact a ECLEVAR representative +33 1 45 01 61 60 or through our site contact form

OUR EXPERTS

Medical Writer

With more than 6 years experience, they are trained to write CEP/CER According to MEDDEV revision 4, MDR 2017/745

Medical experts

More than 50 medical surgeons work in synergy with ECLEVAR to provide clinical inputs.

Regulatory experts

All our regulatory experts held positions at medical device manufacturers and european notified bodies. They are qualified as lead auditors.

Data scientists

OUr data science and analytics teams focus on a variety of projects, from core systems engineering for machine learning and data infrastructure to the use of advanced analytics technologies to provide insights beyond statistical analysis.

ECLEVAR  provide many years of experience working with different notified
body : BSI, SGS, TUV, LNE-GMED.

We know exactly the level of requirements of each notified body and what they are looking for when assessing your technical file for CE marking approval.

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NEWS

EU ISSUES Q&A DOCUMENT TO PROVIDE FURTHER ANALYSIS OF POTENTIAL NO-DEAL BREXIT

Twelve (12) months ago, the EU Commission published a Notice to Stakeholders, “Withdrawal of the United Kingdom and EU Rules in the Field of Industrial Products,”

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EVENTS

JOIN ECLEVAR AT MEDTEC JAPAN

ECLEVAR invites you to meet with us at MedTec Japan in Tokyo, Japan on 18-20 April.

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CAREERS

EXCEPTIONAL CAREERS – INSPIRING EXPERIENCES

Working at ECLEVAR will allow you to apply your expertise and knowledge to make a difference in the lives of others.        Curious about our opportunities ?