Medical Device Regulatory & Market Access Services

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  1. Medical Device Regulatory Consulting Services

    UK & EU MDR Consulting

    Achieve medical device regulatory approval with complete confidence and get UK / EU market access.

    • Technical File Production
    • Clinical Evaluation
    • Systematic Literature Reviews
    • Risk Management
    • Clinical Strategy Development
    • PMS & PMCF
    • Quality Management Systems
    • Further MDR Services
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  2. Clinical Evaluation Reports for UK & EU market access

    Clinical Evaluation

    Market-leading CER & CEP writing services to support UK & EU medical device approvals.

    • Validated & verified CE Process with 100% acceptance
    • CERs & CEPs for UK & EU MDR compliance
    • Complete MedDev & MDCG alignment
    • Fully qualified CER signatories
    • Unlimited post-submission support until full approval
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  3. In vitro Diagnostic Device Regulatory Consulting

    IVDR Consulting

    Ensure guaranteed Notified Body acceptance through expert in vitro diagnostic device regulatory consulting.

    • Technical File Production
    • Performance Evaluation Reports
    • Systematic Literature Reviews
    • Risk Management
    • PMS & PMPF
    • Quality Management Systems
    • Further IVDR Services
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  4. HEOR & Value Communication Planning

    HEOR & Value Communication

    Effectively communicate medical device value to optimise product positioning and drive market share.

    • Burden of Disease
    • Strategic Market Access Planning
    • Evidence Generation Strategy
    • Value Proposition Development
    • Pricing & Reimbursement Strategy
    • Reimbursement Submissions
    • HTA Submission Preparation
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  5. HEOR & Value Communication Planning

    Preclinical Testing

    Ensure validation & verification to harmonised standards through a network of trusted partners.

    • Biocompatibility Testing
    • Usability Testing
    • Electrical Equipment Testing
    • Packaging Standards Testing
    • Other testing services
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Whatever you need, contact us today to start your free, no-obligation consultation.

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