--- title: "Orthopaedic & Spine Medical Device CRO | QbD Group" description: "Clinical evidence for orthopaedic and spine medical devices, from EU MDR strategy and clinical studies to PMCF, market access and long-term implant follow-up." url: https://qbdgroup.com/en/industries/medical-devices/md-cro-orthopaedic-spine type: "Page" language: en publisher: "QbD Group" citation: "QbD Group, \"Orthopaedic & Spine Medical Device CRO | QbD Group\", https://qbdgroup.com/en/industries/medical-devices/md-cro-orthopaedic-spine" --- # 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 25 Studies Executed 46+ Sites Initiated 1,432 Patients Recruited 9 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. Contact us --- Source: https://qbdgroup.com/en/industries/medical-devices/md-cro-orthopaedic-spine — © QbD Group. 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