IVD Consultant | elemed

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IVD Consultant

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elemed is an IVD talent management agency. We connect companies of all sizes who are in need of compliance support with exceptional IVD consultants. Our IVD talent management team have over 50 years of combined experience, and work with the best IVD consultants around the world. elemed specialises in finding consulting professionals for IVD companies that need project support.

Learn more about our approach to providing exceptional IVD support →

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I need an IVD consultant - how can elemed help?

We have an extensive network of IVD consultants within our community, many of whom have decades of experience working with IVDs. 

Some of companies we have provided IVD consultants for include:

  • Global corporations
  • IVD manufacturers
  • High growth IVD startups
  • Notified Bodies
  • Consultancies
  • Contact research organisations

Our team – with 50 years of combined experience – work closely with  IVD consultants and companies daily, giving them a truly in-depth understanding of the complexities and nuances of compliance for IVDs. Whether you’re looking for support with regulatory affairs, quality, clinical, design or something else, we are ready with fantastic IVD consultants – who are subject matter experts -to help.

We support IVD companies with expert consultants in these geographies:

      • DACH
      • Scandinavia
      • Northern Europe
      • Southern Europe
      • France
      • BENELUX
      • US

What support can your IVD consultants offer?

The IVD consultants we work with are experts in a range of specialisms, which means that whatever your project needs are, we can help you find the right person for the job. They work flexibly. which means that they can support your project for as many hours or months as you need. This also means that our consultants are available to start work quickly, with most starting on average within 10 days from when you first contact us.

Areas of support that our MedTech consultants can offer:

  • Global regulatory strategy support
  • Gap assessments of technical documentation (e.g. CE, 510(k); De Novo; PMA, etc)
  • Support Design Control, DHF creation, Risk Management, EUDAMED (UDI), etc
  • EU CE mark NB/CA submissions (significant changes, variations and amendments)
  • SME support (e.g. therapeutic area, regulator experience, etc)
  • EU MDR/IVDR – Sustaining/Maintenance programs post CE approval
  • NB/CA audit questions response support
  • FDA 483 and warning letter responses
  • Project File/Device History File remediation
  • CE mark Technical Documentation remediation – EU MDR/IVDR
  • Clinical Evaluation Reports (CER) and Performance Evaluation Reports (PERs)
  • PMS activity (PMS Plans, PMCF, PSUR)
  • Summary of Safety and Clinical Performance (SSCP)
  • Summary of Safety and Performance (SSP for IVDs)
  • MDR and IVDR Clinical Support
  • Sustaining and Maintenance CER/PERs/PMS
  • ISO 13485, 21 CFR 820 and MDSAP compliance support
  • Economic Operator support (Mfg, Importer, distributor, packaging, supplier, etc)
  • CAPA/NCR services
  • Complaint handling and recalls
  • Process QMS improvement
  • Supplier Auditing/Assessments
  • Internal Auditing
  • Pre-FDA Audit Assessments
  • Pre-MDSAP Audit Assessment
  • MDR/IVDR Audit Assessment
  • Audit readiness (SME, Corporate, etc)
  • Validation Master Plan/Report review and remediation
  • IQ, OQ, PQ validation
  • Support FAT and SAT Process validation (Packaging, Sterilisation, CSV, etc)
  • Performance Improvement (Kaizen, Mfg process improvement, Value Stream Mapping, etc)
  • ISO 14971 Risk management framework and risk assessment
  • dFMEA, pFMEA, uFMEA
  • Risk controls, mitigation, and avoidance
  • Design verification and activities
  • Full Project life cycle management
  • Project planning and KPI
  • Project tracking to scope, milestone, budget, quality standards, etc Working/Steering/Executive Group participation
  • Continuous improvement on standard methodology, tools, management, talent development, etc

What specific products and specialisms can your IVD consultants support with?

    • Class I, II, III medical devices
    • Software as a medical device and digital health
    • Active and non-active medical devices
    • Diagnostics
    • Regulatory, quality and clinical
    • Data science, digital health and AI
    • Cybersecurity in MedTech
    • CDx
    • Sustainability
    • Microbiology and toxicology

Why choose an elemed IVD consultant?

The IVD consultants we work with are leaders in their fields. They have experience with regulatory strategy, classification,  product rationalisation, risk management, labelling, clinical support, PERs, IVDR and much more.

We deliver a shortlist of great IVD consultants within 48 hours on average, with an average ratio of 3 CVs to 1 placed consultant. We’re also more cost-effective than traditional IVD consultancy options.

IVD consultant

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