Eclevar Medtech supports orthopedic and spinal device manufacturers across the entire clinical lifecycle. From early feasibility to registry-linked PMCF and long-term surveillance under EU MDR Annex XIV.
Book a ConsultationTotal hip and knee replacement systems, including primary and revision implants.
Spinal cages, rods, pedicle screws, and complex fusion devices.
Plates, screws, nails, and external fixation systems for fracture management.
Bone graft substitutes, osteoinductive materials, and synthetic matrices.
Under the European Medical Device Regulation (EU MDR), orthopedic and spinal implants face unprecedented clinical scrutiny. Legacy equivalence claims are no longer sufficient. Notified Bodies demand long-term clinical and safety data, radiographic endpoint integration, and continuous PMCF for Class IIb and Class III devices.
Demonstrating clinical safety requires more than patient surveys. Eclevar Medtech integrates standardised imaging protocols into your PMCF to track bone fusion, osteointegration, and radiolucency accurately over time.
Orthopedic and spinal implants are expected to perform for decades. We design ten to fifteen-year PMCF follow-up strategies that satisfy Notified Body expectations for survivorship tracking without overwhelming your budget.
Many legacy devices lack the structured clinical data now required by Annex XIV. Eclevar Medtech remediates historical data and designs high-quality Real-World Evidence (RWE) registries to close these gaps rapidly.
Dr. Nikhil Khadabadi brings a rare dual perspective to orthopedic device studies — a decorated career as an active orthopedic surgeon combined with years at TÜV SÜD as a Senior Clinical Reviewer. He has been on both sides of the Notified Body table.
"Having reviewed hundreds of orthopedic device dossiers at TÜV SÜD, I know precisely what a Notified Body looks for — and where clinical evidence packages fail. That knowledge now serves our clients."
Dr. Nikhil Khadabadi — CMO, Orthopedics & SpineEclevar Medtech utilises a structured and seamless delivery process that connects regulatory strategy, study operations, and digital data collection into one coordinated evidence pathway.
Evaluating existing clinical data and literature against EU MDR Annex XIV requirements to identify specific risks.
Designing targeted clinical investigations, surveys, or registry-based PMCF plans tailored to your specific implant.
Deploying validated Electronic Data Capture systems (MILO EDC) for secure multi-site data and radiographic image collection.
Activating our specialised network of orthopedic investigators and clinics across key European territories.
Authoring audit-ready Clinical Evaluation Reports (CER) and PMCF evaluation reports for the Notified Body.
Implementation of validated Patient-Reported Outcome Measures (PROMs) specific to joint and spine indications. This includes Oxford Hip and Knee Scores, Oswestry Disability Index (ODI), and Neck Disability Index (NDI) to prove objective functional improvement.
Standardised assessment protocols for radiographic endpoints. We facilitate tracking of implant migration, subsidence, bone fusion rates, and radiolucency with independent core lab validation to ensure objective safety data.
Seamless Real-World Evidence (RWE) collection linked to national and European joint registries, such as the NJR and REDIT. Eclevar Medtech helps manufacturers extract and contextualise big data for legacy devices.
Continuous tracking of revision rates, implant survivorship via Kaplan-Meier analysis, and adverse events over a ten to fifteen-year horizon to satisfy the strict post-market requirements of the EU MDR.
Managing long-term orthopedic clinical follow-up requires a robust data infrastructure. Eclevar Medtech utilises MILO EDC, a proprietary Electronic Data Capture platform that is fully compliant with FDA 21 CFR Part 11 and GDPR. The MILO ecosystem integrates eCRF, ePRO, and secure radiographic image uploads in a single, audit-ready environment specifically designed for the medical device industry.
Eclevar Medtech manages the entire evidence continuum. This spans from early pre-clinical strategy and feasibility studies to rigorous Clinical Evaluation Reports and comprehensive post-market surveillance programs.
Our team provides decades of specialised medical expertise in complex implant evaluation, regulatory strategy mapping, and PMCF program design tailored exclusively for orthopedics and spine.
Because our clinical and data management architectures are designed by former Notified Body reviewers, your submission is built to withstand the strictest regulatory audits from day one.
Connect with our Orthopedics & Spine specialists to map out your pathway to EU MDR clinical compliance. Speak directly with Guillaume Charles, Head of Global Business Development at Eclevar Medtech.
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