MDR Consultant | elemed

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elemed is a total talent management agency specialising in MDR, medical devices and diagnostics, dedicated to finding MedTech companies world-class MDR consultants for compliance projects. Our team of total talent managers collaborate with leading medical device companies globally, with a focus on sourcing MDR subject matter experts for the US and European markets.

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What services does elemed offer for MDR consulting?

elemed has a vast network of MDR consultants within our community, many of whom possess extensive experience in the MDR field.

Some of the organisations we’ve supplied MDR consultants for include:

  • International MedTech corporations
  • Medical device and IVD manufacturers
  • Medical device startups
  • Consultancies
  • Contact research organisations
  • Notified Bodies

Our team of talent management consultants are experts in MDR talent, engaging daily with consultants and companies in the field. This means they possess profound knowledge of MDR intricacies, understanding everything from conformity assessments and UDIs to technical documentation and post-market clinical follow-up. This allows us to truly find consultants with the right expertise and skills for your project.

Our medical device consultants are based in:

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

Do you only work with MDR consultants?

We work with a fantastic network of MDR consultants but that’s not all! We also work with consultants across many more medical device and diagnostic functions and specialisms. We work with some of the most experienced MedTech consultants and contractors in the MedTech industry. This highly engaged and highly talented network means we can source fantastic consultants to support with MDR projects and beyond!

Areas of support that our consultants can offer alongside MDR:

  • 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
  • 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 product types and specialisms do elemed MDR consultants also have expertise in?

    • 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 using elemed to find an MDR consultant?

Our network of MDR consultants is unparalleled. We take pride in our profound understanding of what it takes to make a great MDR consultant, allowing us to grasp the intricacies of the MDR projects we recruit for and identify consultants with skills and experience perfectly suited for them.

Our goal is to present you with a shortlist of outstanding MDR consultants within 48 hours, and typically, our MDR consultants commence work within an average of 10 days from our initial discussion. Moreover, we offer a more cost-effective solution compared to traditional MDR consulting options, providing flexibility to accommodate your budget, requirements, and project schedules.

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