Medical Device Regulatory Consulting Services

  • Market-leading regulatory affairs professionals
  • 100% Notified Body acceptance guaranteed
  • 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

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  • 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

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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

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  • 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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  • 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

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  • 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

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  • 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

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  • 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

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  • 310+ Satisfied Clients
  • 77% Return Customers
  • 100% Notified Body Approval

Why Mantra Systems?

We'll help you overcome the key steps in medical device approval ensuring market access for your products

Medical Device Subject Matter Experts
  • Experts in all areas of medical device regulation
  • Professional consultants for worldwide markets
  • Working with all types & classes of medical device
  • Leading medical device regulatory consulting services
  • Guidance & support with Non-Conformity Reports
  • Fixed timelines + commitment to meet your deadlines
  • Named project lead to support you throughout
  • Direct & constant visibility of project progress
  • Unlimited post-submission support until full approval

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Our Clients say

Mantra Systems have provided outstanding quality literature search reports and State of the Art appraisals for our medical devices; I would thoroughly recommend them.

TD

Dr. Trevor Day Principal Scientist Procter & Gamble

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Send an enquiry or book a free discovery meeting to see how we can support your market access strategy