Bringing an aesthetic or skin-contact medical device such as wound dressing to market requires rigorous safety evaluation. Regulators such as
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Missed our live session? Access the full recording now and discover how three leading experts approach real-world evidence (RWE) for
Missed our live session? Access the full recording now and discover how real-world evidence (RWE) and post-market clinical follow-up (PMCF)
WHEN REGULATORY EXPERTISE MEETS CLIENT SUCCESS: A Story from Japan We just received feedback that perfectly captures what we
Wound Care Innovation Podcast – Eclevar MedTech Informative Podcast Wound Care Innovation: Clinical Excellence in Action Discover how advanced clinical
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The rise of real-world evidence alongside controlled clinical trials marks a major evolution in how we evaluate devices in everyday
????️ Safety Continuous monitoring of adverse events, complications, and long-term safety signals across real-world patient populations. ✓ Effectiveness Confirmation that
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At Eclevar, we collaborate closely with healthcare professionals across Europe to improve the way clinical research is conducted in real-life
In this article, we discuss why you should use validated patient reported outcomes (PROs) in your PMCF survey. Under EU
In this article, we discuss the importance of PMCF activities required by EU MDR as part of Post Market Surveillance.
In this article, we would like to talk about some insights for how to write robust CERs complying with MDR
Watch the Full Webinar Topics Covered 1 The True Cost of Data Entry Errors: Budget Impacts and Beyond 2 Building
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Announcement of Chems Hachani, CEO of ECLEVAR, Participation in Oracle’s Webinar Oracle is pleased to announce the participation of Chems
Overview Post-Market Clinical Follow-up (PMCF) requirements under the EU MDR continue to challenge medical device manufacturers with evolving expectations and
Unlock Clinical Insights: Leveraging Level 4 High-Quality Surveys to Close Data Gaps in Orthopaedic Medical Devices Are you facing challenges
As clinical trials become more global and patient-centered, capturing patient experiences accurately across diverse populations is crucial. Electronic Patient-Reported Outcomes
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Reducing Respondent Burden in Patient-Reported Outcome (PRO) Data Collection ???? In this whitepaper, you’ll find: Strategies for minimizing respondent burden
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Key Components of a Clinical Evaluation Report: Essential Sections and Their Content ???? In this whitepaper, you’ll find detailed insights
Reforming Clinical Evaluation of Medical Devices in Europe In this whitepaper, you’ll find detailed insights on: The clinical evaluation process
A Comprehensive Guide to Clinical Investigations with Medical Devices in Europe: Pre- and Post-Market Requirements ???? In this whitepaper, you’ll
SAE Reporting in Germany: A Guide for Clinical Investigations under MDR 2017/745 ???? In this whitepaper, you’ll find detailed insights
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Prepare for the Future: Navigating UKCA Marking and Regulatory Changes for MedTech ???? In this whitepaper, you’ll find detailed insights
The market of orthopedic and spine medical devices is increasing through innovation and is estimated to be $30 billion in
Paris, October 21, 2024 – Eclevar MedTech, a leading european contract research organization (CRO) specializing in medical devices, proudly announces
Paris, October 03, 2024 – Eclevar MedTech, a leading european contract research organization (CRO) specializing in medical devices, proudly announces
# Presenting eConsent in Clinical Trials Traditional paper-based consent forms were long and difficult to read, requiring over a ninth-grade
Top 10 eCRF Platforms in 2025 – Eclevar MedTech Electronic Case Report Forms (eCRFs) are vital in the always evolving
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The European Commission’s Medical Device Coordination Group (MDCG) is alerting that medtech manufacturers get certified under the new device and
We are thrilled to announce our participation as an exhibitor at the Paris Vascular Insights (PVI) 2023 event! This three-day program
We are thrilled to share some exciting news with our esteemed readers and industry peers. ECLEVAR MEDTECH is honored to
ECLEVAR MEDTECH, a French based CRO specialized in medtech industry, enters into a partnership with Micron, a Japanese domestic CRO,
We are pleased to announce to organize the joint educational webinar on Tuesday, September 5th at 16:00(JST). This joint webinar
What are the major changes introduced by the EU MDR compared to previous regulations? The Regulation EU 2017/745, commonly known
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How to guarantee expert Clinical Data Analysis in Trials for new Medical Devices Clinical Data Analysis is a crucial step
Expert Clinical Trial Protocol Development Services Before a clinical trial can be started, a Clinical Trial Protocol must be developed.
What are the experienced CRO solutions available for Medical Device EMA Compliance? European Medicines Agency is the organ responsible for
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A Clinical Evaluation Report (CER) is a document that exposes a clinical assessment’s conclusions of a medical device. The report
ECLEVAR MEDTECH, a Paris-based global CRO, has announced that it will provide clinical trial services using the Oracle Clinical One
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Join us for an insightful webinar that will equip you with the knowledge and skills necessary to navigate the complexities
The Japanese market for medical devices is expanding rapidly, presenting significant opportunities for pharmaceutical and medical device companies. Japan’s aging
Regulatory Authority in Japan The authorization of medical devices in Japan represents a challenge for European manufacturers. But it’s not
In the European Union, medical devices are divided into four categories based on their intended use and level of risk.
