IVDR Consultant | elemed

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IVDR Consultant

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elemed is a talent management agency specialising in In Vitro Diagnostic Regulation (IVDR) consultants and compliance support. We facilitate connections between companies of all sizes requiring compliance project support and top-tier consultants. With over 50 years of collective experience, our talent management team collaborates with leading consultants globally who can support with:

  • regulatory strategy,
  • classification,
  • product rationalisation
  • technical documentation and compilation of risk management
  • labelling
  • clinical support
  • PERS and clinical report strategy
  • IVDR maintenance
  • assistance with notified bodies and competent authorities for IVDR for companion diagnostics
  • and much more

     

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Discover more about elemed  

How can elemed assist me in finding an In Vitro Diagnostic Regulation consultant?

We have an extensive network of consultants within our community, many of whom have decades of experience working with IVDs and IVD regulations. We also pride ourselves on our agility and efficiency in meeting your needs. Within just 48 hours of our initial conversation, we can deliver a carefully curated shortlist of IVDR consultants tailored to your specific requirements. What’s more, once you’ve made your selection, our streamlined process ensures that your chosen consultant can start working with you within a mere 10 days, expediting the commencement of your project and minimising any delays in achieving your goals. 

Some of the businesses we have provided IVDR consultants for include:

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

     

Our team, with over 50 years of combined experience, works closely with consultants and IVD companies daily, giving them a truly in-depth understanding of the complexities and nuances of compliance for IVDs. We are ready with fantastic consultants – who are subject matter experts – to help prepare your business for the IVD regulation and beyond. We support companies with expert consultants in these geographies:

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

Can your consultants offer support outside of IVDR services?

The consultants we collaborate with are specialists in various disciplines, ensuring that we can match you with the ideal individual for your project requirements. They offer flexible support, accommodating your project’s timelines and duration. Additionally, our consultants are readily available to commence work immediately, with most starting within an average of 10 days from your initial contact with us.

Other services our 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 products and specialisms can your 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

What are the benefits of working with an elemed consultant?

The consultants we collaborate with are industry-leading experts in their respective domains. They possess extensive experience in regulatory compliance, quality management systems (QMS), clinical performance evaluations, validation, labelling and IFU, risk management, post-market surveillance, biocompatibility, software validation, complaint handling and corrective actions, and training and competency.

On average, we provide a curated shortlist of exceptional consultants within 48 hours with an average ratio of 3 CVs to 1 placed consultant. Moreover, our services are more cost-effective compared to traditional consultancy options.

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