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
???? What is Real-World Data?Real-world data (RWD) refers to health information gathered outside the controlled settings of clinical trials, such
Reducing Respondent Burden in Patient-Reported Outcome (PRO) Data Collection ???? In this whitepaper, you’ll find: Strategies for minimizing respondent burden
How Psychometrics Influence PRO Selection for Clinical Trials ???? In this whitepaper, you’ll find detailed insights on: The importance of
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
Mastering Vigilance Reporting Requirements in Germany: A Guide for MedTech Professionals ???? In this whitepaper, you’ll find detailed insights on:
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
Electronic Case Report Forms (eCRFs) are vital in the always evolving landscape of clinical research. They help gather, manage, and
The prevalence of Crohn’s Disease (CD) is on the rise, impacting almost 500,000 people in America alone. CD falls under
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
What is the importance of PMCF (Post-Market Clinical Follow-up) as an essential element of medical device regulation? Post-Market Clinical Follow-up
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
The heart is a vital organ responsible for pumping blood throughout the body, ensuring oxygen and nutrients are delivered to
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.
Selecting the right Contract Research Organization (CRO) in the development and commercialization of medical device When it comes to choosing
The European regulatory landscape has significantly changed over the past 10 years, particularly concerning requirements for Clinical Evaluation (CEP/CER). This
Summary Eclevar MedTech can assist manufacturers to comply with post-market surveillance requirements for medical devices. The manufacturer should establish and
Eclevar Australia provides an update on Australian regulatory pathway for breakthrough innovative medical devices – March 2023 The TGA priority
Learn more about Software and Artificial Intelligence as a Medical device in UK Software and Artificial Intelligence as a medical device
Eclevar Australia provides an update on Australian regulatory requirements for personalized including 3D printed medical devices – February 2023 TGA
Creating the Future in Clinical Research with CROs Using Real-World Data Tuesday, February 14, 2023, 9 am CT, 10 am
A shift to an international approach to safety and performance? Regulators across the globe know, only to well, the challenges
Eclevar Australia provides an update on TGA acceptance of overseas approvals for ARTG inclusion of medical devices – December 2022
PMCF is considered under the regulations to be a continuous process that has two critical functions – Firstly it is
If you wish to place a medical device on the US market, and a Premarket Approval Application(PMA) is not required,
Eclevar Australia provides an update on Australian regulatory requirements for software-based medical devices – January 2023 TGA is aligning its
We are proud that ECLEVAR will work closely with the British government on the future study of EU regulation in
Introduction The principle of ISO 14155:2020 Annex I post-market stage applies to clinical investigations as per MDR 2017/745 Article 74.1
MedTech Digital Week PMCF Clinical Investigations and Other Studies 04 Oct 2022 – Question and Answers Introduction On 04. October
Are the Australian regulations for medical devices aligned with the new EU Medical Devices Regulation and In Vitro Diagnostic Medical
Introduction While under the MDD 93/42/EEC and AIMDD 90/385/EEC and Medizinproduktegesetz (Medical Device Act, MPG) the submissions for pre-CE mark
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Introduction For post-market follow-up clinical investigations (PMCF CI) as per Art 74(1) MDR 2017/745, submissions to the Ethics Committee (EC)
PMCF – What’s the use of a survey? Post Market Clinical Follow-up (PMCF) is the subject of much debate. PMCF
MDCG Guidance documents summary series: Introduction Under MDD and AIMDD already it was required to provide patients with an
When a medical device is placed on the market, it is subject to Post-Market Surveillance (PMS) according to MDR 2017/745.
Post-market Clinical Investigation with Medical Devices in Europe as per ISO 14155:2020 and MDR 2017/745 Introduction This blog summarizes the
Our Eclevar experts will answer your questions and guide you through the next steps!
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