UK & EU MDR Consulting Services

Guaranteed Regulatory Approval for your Medical Devices

  • Market-Leading Regulatory Services
  • Complete MedDev & MDCG Alignment
  • Ongoing Notified Body Support

Contact us today

We support you all the way to MDR approval

  • Professional consulting specific to your needs
  • Free gap analysis + tailored service recommendations
  • We work with devices at all stages of their approval journey

Guaranteed alignment with MDR requirements

  • Unlimited start-to-finish support
  • Guaranteed final Notified Body approval
  • We are invested in your success
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We design the most efficient route to MDR approval

  • Improved ROI through effective project plans
  • Save time & money by eliminating errors
  • We have experience over hundreds of MDR submissions

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Contact us to book your free, no-obligation consultation call

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MDR Consulting Services for your devices

Achieve EU & UK MDR approval with complete confidence

  • Technical File Production

    Secure medical device approval through professional & tailored technical file production.

    • Complete drafting of MDR Annex II & III technical documents
    • Optimising intended purpose, indications and target populations
    • Collating device description, design history & manufacturing information
    • GSPR relevancy, conformity & gap analysis
    • Designing labelling, IFU & information supplied with device
    • Compilation to align with latest MDCG & IMDRF guidance

    Get in touch to discuss this with our team

  • Clinical Evaluation

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

    • Validated & verified CE process with 100% acceptance
    • CERs & CEPs for EU & UK MDR compliance
    • Complete MedDev & MDCG alignment
    • Fully qualified CER signatories
    • Unlimited post-submission support until full approval

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  • Systematic Literature Reviews

    Comprehensive literature search & reviews crafted around your objectives, delivered by subject matter experts.

    • SOTA Reviews for Clinical Evaluation & Competitor Analysis
    • Protocol development using validated methodology
    • Structured inclusion / exclusion screening with full traceability
    • Weighted meta-analysis for Safety & Performance Benchmarking
    • Evidence appraisal & analysis from professional medical writers
    • Fully MedDev, MDCG & PRISMA compliant

    Get in touch to discuss this with our team

  • Risk Management

    Optimise device and process design through powerful & targeted Risk Management consulting.

    • Full ISO 14971:2019 Risk Management File production
    • Risk Analysis by clinical subject matter experts
    • Risk Controls, Design / Process Inputs & QMS integration
    • Evidence-based Benefit-Risk Analysis
    • Risk Management Reviews, Reports & updates

    Get in touch to discuss this with our team

  • Clinical Strategy Development

    Enhance go-to-market positioning through development of a clinical evidence strategy aligned to your commercial & regulatory goals.

    • Expert consulting on all aspects of Clinical Strategy Development
    • Fine-tuned progression from pre-clinical & first-in-human to pivotal & PMCF studies
    • Alignment with intended purpose, clinical benefits & competitive advantages
    • Tailored evidence generation strategy & Clinical Development Plan
    • Optimisation of clinical budget allocation

    Get in touch to discuss this with our team

  • PMS & PMCF

    Safeguard device approvals through comprehensive PMS & PMCF systems tailored to your products.

    • Align with Clinical Evaluation, Risk Management & commercial priorities
    • Producing PMS Plans & PSURs according to MDR Annex III
    • Writing PMCF Plans, Reports & ISO 14155:2020-compliant Study Protocols
    • Adherence to ISO/TR 20416:2020, MDCG 2020-7 & relevant MedDev guidelines
    • GDPR-compliant data collection & storage with ISO certified EDC systems
    • Data collation, statistical analysis and reporting

    Get in touch to discuss this with our team

  • Quality Management Systems

    Drive world-class quality & continuous process improvement with an ISO 13485:2016-compliant QMS.

    • Network of specialist ISO 13485:2016 QMS consultants
    • Development of QMS for new-to-market & established devices
    • Gap Analysis of existing QMS
    • eQMS & digital document management system providers

    Get in touch to discuss this with our team

  • Further MDR Services

    Complete your MDR submission through additional services specific to the needs of your products.

    • Writing SSCPs for healthcare professionals & lay persons
    • Readability testing protocols, studies & reports
    • Development of Medicinal Dossiers for combination products
    • Support with Notified Body applications
    • Completion of Declaration of Conformity
    • Allocation of PRRC & Authorised Representative

    Get in touch to discuss this with our team

Why Mantra Systems?

We are your partner to full MDR approval, solving regulatory challenges through tailored routes to compliance

Medical Device Subject Matter Experts

What you get with Mantra Systems…

  • Experts in all types & classes of device
  • Personalised project plans to suit your needs
  • Named project lead to support you throughout
  • Flexible payment options with no hidden costs
  • Direct & constant visibility of project progress
  • Regulatory professionals & real medical experts
  • Unlimited post-submission support until approval

Contact us today to book a free consultation

Are you looking for…

  • Expert UK & EU MDR consultants?
  • A quote for our services?
  • Help understanding your options?

Whatever you need, contact us today to start your free, no-obligation consultation.

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