Combination Device Consultants | elemed

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Device Consultant

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elemed is a leading total talent management agency focusing on combination device expertise and regulatory compliance. We specialise in connecting businesses of all sizes with top-tier consultants skilled in navigating combination device compliance, quality and regulations. Drawing upon more than five decades of combined experience, our team at elemed works closely with highly experienced consultants from around the world. We are adept at sourcing professionals well-versed in regulatory affairs, quality, and clinical affairs for combination devices, to assist companies with their compliance projects.

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How can elemed help me find a combination device consultant?

elemed has an extremely well established network of Medtech professionals, many of whom are combination device consultants with a wealth of experience in regulatory, quality and clinical specifically relating to combination devices.  Our talent management team prides itself on its flexibility and efficiency in meeting your needs. Within just 48 hours of initial contact, we can provide you with a carefully curated shortlist of combination device consultants tailored to your requirements. Moreover, once you’ve made your selection, our streamlined process ensures that your chosen consultant can commence work within 10 days on average, ensuring a swift start to your project and minimising any potential delays.

We have partnered with a diverse range of businesses seeking combination device consultants, including:

  • Large global corporations
  • Combination device manufacturers
  • Emerging combination device startups
  • Notified Bodies
  • Consulting firms
  • Contract research organisations

With over 50 years of combined experience, our team works closely with combination device consultants and companies on a daily basis, giving us a deep understanding of the complexities of combination device compliance. We are equipped with exceptional combination device consultants who are subject matter experts, ready to assist your business in navigating combination device regulations, quality and compliance. Our support extends to companies across various geographies, including:

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

How can your combination device consultants support my project?

The combination device consultants we partner with have a range of different skills and experienes, guaranteeing we find the perfect fit for your project needs. They provide adaptable assistance, aligning with your project’s schedule and length. Moreover, our consultants are ready to start quickly, with most starting work on your project within around 10 days of your first interaction with us.

Areas of support our combination device 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
  • 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 areas of expertise do your combination device consultants have?

    • 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 advantages of working with an elemed combination device consultant?

We collaborate with leading experts in the field of combination devices. They possess extensive experience in technical documentation to fulfil EU MDR Article 117 requirements, regulatory strategy for the US and EU market for drug device combination products, assistance with the device portion of a eCTD submission through traditional 510k, de novo filing and pre-market approvals, support with Design History File (DHF) creation and remediation for combination products, inclusive of Human Factors support, and various other relevant areas relating to combination device products.

On average, we provide a curated shortlist of exceptional combination device 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 combination device consultancy options.

combination device consultant

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