Now Hiring • Tokyo, Japan Clinical Project LeaderEU-Japan Corridor Lead our Japan clinical operations hub, build the PMDA–EU MDR data bridge, and grow our KOL
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Now Hiring • Tokyo, Japan Clinical Project LeaderEU-Japan Corridor Lead our Japan clinical operations hub, build the PMDA–EU MDR data bridge, and grow our KOL
Market Access Strategy CE Mark is Not the Finish Line: Why Adoption Still Stalls in the NHS For orthopaedics, spine, and robotics, regulatory approval is
Precision is Easy to Measure, Value is Harder to Prove | Eclevar MedTech Orthopaedic Robotics Precision is easy to measure, value is harder to prove:
Press Release Eclevar MedTech Appoints Nancy Boodhun as Chief Clinical Operations & Strategy Officer Eclevar MedTech today announced the appointment of Nancy Boodhun as Chief
????️ Full Replay EU MDR Masterclass: Expert Insights from TÜV SÜD & AKRA TEAM Classification pitfalls, clinical data strategies, technical file essentials, and compliance
???? Award-Winning Team Eclevar MedTech Secures Platinum Award xShare Open Call for Clinical Research ???????? European Commission Co-Funded Initiative This prestigious recognition honors the vanguard
Meet Our HRIPT & SPT Experts Dr. Nikhil Khadabadi Chief Medical Officer Orthopedics & Spine Dr. Nikhil brings extensive clinical expertise in dermatological safety assessments
How to Select Sites for Diabetic Foot Ulcer (DFU) Studies in Wound Care Medical Device Investigations Teot Luc Scientific Coordinators and board members for DFU
Aesthetic Devices Under EU MDR Annex XVI, Section 5 “Substances, combinations of substances, or items intended to be used for facial or other dermal or
Dr. Mark Da Costa Cardiac Surgeon, TUV-SUD Consultant With over 30 years of clinical experience and expertise in medical device review, Dr. Da Costa provides
AESTHETIC MEDICAL DEVICES How to Use the FACE-Q Survey to Collect High-Quality Clinical Data for Fillers and PRP Treatments In today’s aesthetic medical device market,
Missed our live session? Access the full recording now and discover how three leading experts approach real-world evidence (RWE) for orthopaedic devices under the Medical
Dr. Mark Da Costa Consultant Cardiac & Cardiovascular Surgeon, TÜV SÜD With over 30 years of clinical experience and expertise in medical device
Missed our live session? Access the full recording now and discover how real-world evidence (RWE) and post-market clinical follow-up (PMCF) are revolutionizing cardiovascular device development
Informative Podcast Wound Care Innovation: Clinical Excellence in Action Discover how advanced clinical trials and regenerative medicine are transforming wound care outcomes across Europe
The Essential Role of RWD & RWE in Medical Device Development In this comprehensive guide, we explore the critical value of real-world data (RWD) and
The rise of real-world evidence alongside controlled clinical trials marks a major evolution in how we evaluate devices in everyday care. Over the past decade
????️ Safety Continuous monitoring of adverse events, complications, and long-term safety signals across real-world patient populations. ✓ Effectiveness Confirmation that orthopaedic devices deliver intended clinical
How the CER and the PMCF Plan are related with each other? Under the EU MDR, the PMCF Plan is a part of technical files
In this article, we discuss why you should use validated patient reported outcomes (PROs) in your PMCF survey. Under the EU Medical Device Directive
Learn why PMCF is mandatory under EU MDR. Understand post-market clinical follow-up requirements, regulatory background, and PMCF activity options for device compliance.
Why is Writing the CER Under EU MDR Challenging? Compared to the MDD, MDR expects a higher standard for the CER. MedDev 2.7/1 rev4
Watch the Full Webinar Topics Covered 1 The True Cost of Data Entry Errors: Budget Impacts and Beyond 2 Building Trust: How High-Quality Data Strengthens
Watch the Full Webinar About This Webinar ISO 14155 is the international standard for good clinical practice (GCP) in clinical investigations of medical devices for
Overview Post-Market Clinical Follow-up (PMCF) requirements under the EU MDR continue to challenge medical device manufacturers with evolving expectations and rigorous evidence demands. Join us
WEBINAR REPLAY – Cardiovascular Device Compliance: Navigating the EU MDR Landscape Key Topics to be Covered Key Topics to be Covered Introduction to Cardiovascular Medical
WEBINAR REPLAY : Unlocking Clinical Insights: Leveraging Level 4 High-Quality Surveys to Address Clinical Data Gaps for Orthopaedic Medical Devices Are you facing challenges with
Clinician-Led Excellence in Orthopedics & Spine Dr. Nikhil Khadabadi, MD, MS, MRCS Chief Medical Officer – Orthopaedics & Spine “With over 15 years of experience
We’re thrilled to announce that Eclevar has collaborated with BSI to publish a comprehensive whitepaper: “EU MDR – Post Market Clinical Follow-Up: Gaining Real-world Evidence
Led by Wound Care Experts Our scientific advisory board includes internationally recognized wound healing specialists Scientific Advisory Board Prof. Luc Teot Head of Wound Healing
6 EU MDR Compliance Strategies for Medical Device Manufacturers (2026 Edition) | Eclevar MedTech EU MDR 2017/745 — 2026 Edition 6 EU MDR Compliance Strategies
Ethical and efficient participant onboarding is crucial to the successful development of clinical trials. The informed and voluntary consent process is a key
FDA Audit Preparation | Comprehensive Guide for Medical Devices One of the top concerns about FDA inspections is the lack of preparedness and uncertainty about
510(k) Clinical Studies Guide | Eclevar MedTech CRO Insight on 510(k) Clinical Studies: An In-depth Guide Comprehensive guide to understanding 510(k) clinical studies, regulatory requirements,
Streamline data collection, improve accuracy, and accelerate drug development with electronic patient-reported outcomes technology. Clinical trials are a critical component of the drug
Understanding the 510(k) Certification Process: A Comprehensive Guide Gain valuable insights into the 510(k) certification process, a crucial step for medical device market
What is Clinical Trial Monitoring? Clinical Trial Monitoring plays a crucial role in ensuring the well-being of participants and evaluating the effectiveness of treatments
In clinical trials, the site refers to the physical location—typically a hospital or healthcare facility—where practical trial activities are performed. Ensuring adequate infrastructure,
Clinical Data Management for Medical Devices — EU MDR Solutions 2026 | Eclevar MedTech Clinical Data Management for Medical Devices — 2026 Edition Clinical Data
Contract Research Organisation | Innovative Clinical Research Solutions CRO Services Overview Affordable Clinical Trials Management for Medical Device Development Designed to reduce costs for companies
Medical Device Reimbursement in Europe — Country-by-Country Guide 2026 | Eclevar MedTech Market Access · Reimbursement Strategy · Updated 2026 Medical Device Reimbursement in Europe
Japan-EU Corridor Strategy · PMDA & EU MDR 2017/745 Introducing Medical Devices in Japan & Europe — EU MDR and PMDA Corridor Strategy Japan
Strategic Guide The Critical Decision in Medical Device Development When it comes to choosing the right Contract Research Organization (CRO) there are many service
Develop a comprehensive PMCF plan under EU MDR. Learn strategic planning, timelines, regulatory requirements, and best practices for post-market clinical follow-up.
Regulatory Guide 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 clinical investigations
Learn how PMCF surveys collect post-market clinical data for medical devices. Explore survey design, implementation, regulatory compliance, and best practices under EU MDR.
PRRC – An overview of the role and requirements of the person responsible for regulatory compliance under Article 15 of EU MDR and EU IVDR.