Webinar: Orthopaedics and Spine under EU MDR | Eclevar MedTech
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Orthopaedics and Spine under EU MDR: Notified Body expectations, device development, and clinical evidence

Join a leading Notified Body Assessor, an Academic Engineering Expert, and a Former TUV SUD Assessor. Get a complete, practical roadmap covering everything from mechanical validation to clinical strategy and post-market evidence.

Platinum Award EUCROF 2026 Organized by Eclevar MedTech
Platinum Award EUCROF 2026
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The Agenda

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From pre-clinical testing to post-market compliance — get instant access to the recording and discover all three sessions below.

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Session 1

Engineering & Device Development

By Dr. Nicolas Newell

A deep dive into design, verification, and validation. Learn how to leverage physiological testing and rapid computational design assessments to optimise safety and meet the highest required testing standards.

Session 2

Notified Body & Regulatory Expectations

By Dr. Saman Tavana

Direct insights from a current SGS Assessor. Understand exactly what Notified Bodies expect for orthopaedic and spinal devices under the rigorous EU MDR frameworks, identifying red flags before submission.

Session 3

Clinical Evidence Strategy & PMCF

By Dr. Nikhil Khadabadi

Navigating the clinical evaluation and PMCF pathway. Discover how to build registries and post-market evidence programs that secure market access and guarantee long-term lifecycle compliance.

Speakers

Meet the Panel

An exclusive convergence of regulatory assessment, academic engineering excellence, and specialized clinical operations.

Dr. Nicolas Newell
Dr. Nicolas Newell
Assistant Professor, Imperial College London
Spine BiomechanicsPre-clinical Testing

A mechanical engineer running the Newell Spine Lab and Director of Metisec Ltd. Working at the intersection of academia and industry, Dr. Newell develops novel capability to test spinal devices physiologically and provides rapid computational design assessments.

Dr. Saman Tavana
Dr. Saman Tavana
Senior Technical & Clinical Product Assessor
SGS Notified Body 1639Orthopaedics & Dental

Dr. Tavana serves as a Senior Product Assessor at SGS Belgium. Evaluating technical documentation directly from the Notified Body's perspective, he provides vital clarity on how the EU MDR is currently applied to complex orthopaedic technologies.

Dr. Nikhil Khadabadi
Dr. Nikhil Khadabadi
CMO Orthopaedic & Spine, Eclevar MedTech
Former TUV SUD AssessorRobotics & Implants

Having evaluated hundreds of clinical evidence packages at TUV SUD, Dr. Khadabadi builds PMCF programs and Clinical Evaluation Reports from the inside out, ensuring manufacturers navigate the MDR transition with absolute confidence.

"Having rejected submissions from the other side of the table, I know success relies on removing ambiguity."

Ready to align your strategy with Notified Body expectations?

Register now to secure your spot for this live expert panel. Bring your toughest questions regarding pre-clinical testing, clinical evidence, and regulatory hurdles.

Reforming Clinical Evaluation of Medical Devices in Europe