IVD Regulatory Consulting Services

  • Get IVDR approval with complete confidence
  • 100% Notified Body acceptance guaranteed
  • Achieve market access for your IVD devices

  • Technical File Production

    Obtain first-time IVD device approval through professional & tailored technical file production.

    • Complete drafting of IVDR Annex II & III technical documents
    • General device description, specification & analytical performance
    • 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 design and user interfaces while driving IVDR compliance through powerful & targeted Risk Management consulting.

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

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  • Systematic Literature Reviews

    Build a solid foundation for any IVDR submission through market-leading literature reviews by subject matter experts.

    • SOTA Literature Reviews for Scientific Validity, Performance Evaluation & Competitor Analysis
    • Protocol development using PICO methodology
    • Structured inclusions / exclusions with full traceability
    • Weighted meta-analysis supporting scientific validity
    • Evidence appraisal & analysis from professional medical writers
    • Fully MedDev, MDCG & PRISMA compliant

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  • Performance Evaluation Reports

    Secure IVDR approval through market leading Performance Evaluation drawing upon medical, regulatory and professional writing expertise.

    • Validated PER Process with 100% acceptance
    • Scientific Validity, Analytic Performance & Clinical Performance Reports
    • Complete MedDev & MDCG compliant PEP & PER writing service
    • Fully qualified signatories
    • Unlimited post-submission support until full approval

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  • PMS & PMPF

    Protect IVD approval through robust PMS & PMPF systems designed to ensure long-term market access.

    • PMS & PMPF system design tailored to your in vitro diagnostic device
    • Producing PMS Plans & PSURs according to IVDR Annex III
    • PMPF Plans, Reports & ISO 14155:2020-compliant Study Protocols
    • Writing PMPF Plans & Reports
    • Adherence to ISO/TR 20416:2020, MDCG 2022-2 & MDCG 2024-4
    • Data analysis & updates to Performance Evaluation, benefit-risk & other technical documents

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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 IVDs
    • Gap Analysis of existing QMS
    • eQMS & digital document management system providers

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  • Further IVDR Services

    Leave no stone unturned through bespoke consulting for device-specific circumstances.

    • Shelf life, in-use & shipping stability reports
    • Support with Notified Body applications
    • Completion of Declaration of Conformity
    • Allocation of PRRC & Authorised Representative
    • Specialist services for software as an IVD

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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