Your CRO for Orthopaedic & Spine Medical Devices

Clinical evidence built for EU MDR, PMCF and market access

Orthopaedic and spine studies bring specific clinical and operational challenges, from surgeon and site selection to imaging, PROMs and long-term implant follow-up. QbD Group combines medical device CRO execution with regulatory and scientific expertise to build the evidence for your implant, spine or surgical technology, from strategy to post-market follow-up.

Overview

A CRO Dedicated to Orthopaedic Devices

Orthopaedic and spine studies demand more than standard CRO delivery. Surgeon and site selection, standardised surgical technique, imaging and radiographic endpoints, PROMs, rehabilitation pathways and long-term follow-up all influence data quality, timelines and cost.

QbD Clinical is a European medical device CRO that combines clinical operations with regulatory and scientific expertise to design pragmatic evidence strategies and deliver them across Europe. We support joint prostheses, endoprostheses, spinal systems, surgical instruments and navigation-enabled technologies, from pre-CE investigations through post-market clinical follow-up (PMCF).

Our objective is to generate the evidence required for EU MDR compliance, market access and your next development milestone, through efficient, fit-for-purpose study designs.

Orthopaedic & Spine Track Record

Studies Executed

46+

Sites Initiated

1,432

Patients Recruited

European Countries

Pre-CE and post-CE experience across Germany, Belgium, the Netherlands, Switzerland, Austria, Italy, Spain, the UK and Ireland.

Why Specialisation Matters

The Realities We Design For in Orthopaedic Studies

Orthopaedic and spine trials succeed or fail on details a generalist CRO can miss. We plan for them from day one.

Surgeon & Site Strategy

Investigator fit, surgical volume and standardised technique to protect data quality.

Recruitment & Patient Pathways

Realistic feasibility across indications, eligibility and referral pathways.

Imaging & Radiographic Endpoints

Radiographic assessment, core-lab alignment and consistent measurement.

PROMs & Functional Outcomes

Validated PROMs and clinically meaningful functional endpoints.

Rehabilitation Considerations

Rehabilitation pathways built into protocol design and follow-up windows.

Implant Survivorship & Revisions

Long-term implant survivorship, revision tracking and PMCF follow-up.

More Than a Clinical CRO

The Full MedTech Evidence Package, Under One Roof

As orthopaedics adopts navigation, robotics, software and connected technologies, evidence needs to span disciplines. QbD Group brings them together, so you're not stitching together vendors across the lifecycle.

Clinical CRO

Study design, operations, monitoring, PROMs, imaging and CSR.

Regulatory Affairs

EU MDR strategy, Notified Body coordination, CER and PMCF.

Quality Assurance

QMS, ISO 13485 and audit-ready documentation.

Biocompatibility

ISO 10993 biological evaluation for implant materials.

Software & SaMD

IEC 62304, validation and eIFU for connected and navigation technology.

From eIFU to full clinical partner. Many orthopaedic manufacturers start with us on a single service and grow into full clinical and regulatory programs as their device and evidence needs mature.

Client Cases

Orthopaedic & Spine Client Cases

Selected engagements showing how we combine clinical, regulatory and software expertise. Anonymised.

Ortho | First-In-Human

Indication: High-risk implantable orthopaedic device
Study Type: First-in-human / revised protocol
Regulatory: FAGG Belgium, DSMB established
Services: Combined RA roadmap for implant and software on one timeline, hands-on RA support

Ortho | Hip Implant + Software

Indication: Hip implant with companion software
Study Type: MDR transition / combined EU roadmap
Markets: European Union
Services: EU roadmap grouping the kit into manageable device families rather than item by item

Surgical | Instruments

Indication: Surgical kits: drill sleeves, guides, tools
Study Type: MDR classification & roadmap
Markets: European Union
Services: Sequenced four-region roadmap reusing evidence across markets

Surgical | Drill Chucks

Indication: Surgical drill chucks
Study Type: Multi-region regulatory roadmap
Markets: EU, US, Canada, Australia
Services: Protocol review, clinical development plan, medical expert workshop, submission

Client Cases

Regulatory Challenges, Resolved

Where authority questions arose, our experience turned them into fast, compliant outcomes.

Study Design & DSMB

Challenge: FAGG Belgium questioned a first-in-human study design over potential bias and requested a Data Safety Monitoring Board.

QbD Group Solution: A protocol review workshop with our in-house medical expert and two clinical experts built a revised development plan and set up the DSMB.

Outcome: Resubmitted and accepted without further questions, with minimal timeline impact.

Incomplete Submission

Challenge: A submission was rejected over a missing insurance certificate referencing the Belgian medical device law of December 2024.

QbD Group Solution: A gap assessment and fully compliant resubmission within one week, refining exclusion criteria and informed consent.

Outcome: Conditional approval in March 2024, with all conditions cleared by June 2024.

Technical Documentation

Challenge: Authorities requested additional risk analyses, biological evaluations and design verification beyond the concise initial dossier.

QbD Group Solution: All requested documentation was provided promptly during the RFI phase, with the staged submission strategy adjusted to authority expectations.

Outcome: Accepted with no further requests and no timeline delays.

Medical Advisory Board

Orthopaedic Expertise Built Into Your Study Strategy

Direct access to an experienced orthopaedic surgeon who can challenge protocol design, endpoints, country and site selection, and your overall clinical development strategy.

Prof. Dr. Djordje Lazovic

Orthopaedic Surgeon & Professor

Orthopaedic surgeon and professor at the European Medical School Oldenburg-Groningen
Specialised in knee surgery, endoprosthesis and surgical navigation
Recognised expert in orthopaedics and biomechanics
Advises sponsors on pivotal trial design, endpoints and strategic country selection

Protocol & Endpoints Strategy

Clinical input to make study design and endpoints relevant, pragmatic and executable.

Independent Clinical Oversight

Input on study design and protocol, independent Medical Monitor, CEC / DSMB member.

Evidence & Risk Assessment

Development planning, risk assessment, validating clinical relevance.

Country & Site Strategy

Clinical perspective on country selection, investigator fit and operational feasibility.

End-to-End Delivery

Orthopaedic Study Workstreams

Build the right evidence package from study design to PMCF, with QbD Group's clinical, regulatory and wider MedTech expertise under one roof.

Feasibility, Surgeon & Site Strategy

Protocol, Endpoints & Clinical Strategy

Regulatory Submissions & Safety Oversight

Clinical Safety Management

Monitoring & Clinical Trial Operations

Imaging, PROMs & Data Management

Biostatistics, Analysis & Medical Writing

CER, PMCF & Post-Market Evidence

FAQ

Orthopaedic Device Clinical Trials: Common Questions

Build an orthopaedic evidence strategy fit for your next milestone

Whether you're refining your clinical strategy or launching a pivotal orthopaedic or spine study, our clinical and regulatory experts are ready to support your MedTech journey, from gap assessment to full CRO delivery.