MedTech Consultant | elemed

Find a

MedTech
Consultant

Fast. Agile. Staffing

elemed is a MedTech talent management agency that connects medical device and diagnostic companies who are looking for support with compliance projects to exceptional MedTech consultants. Our talent management experts – with over 50 years of combined experience – work with the brightest medical device and diagnostic talent in the world and specialise in sourcing consulting professionals for companies that need project support.

Some of the areas our consultants can support with are:

  • Overseeing compliance with regulations set by government agencies such as the FDA (Food and Drug Administration) in the United States, EMA (European Medicines Agency) in Europe, and other relevant authorities worldwide
  • Quality management systems (QMS) – development and maintenance to ensure products consistently meet quality standards and regulatory requirements including ISO 13485
  • Identifying, assessing, and mitigating risks associated with medical devices throughout their lifecycle
  • Ensuring compliance with regulations governing the design, conduct, and reporting of clinical trials, including adherence to Good Clinical Practice (GCP) guidelines
  • Implementing new product design procedures to ensure that products are developed in accordance with regulatory requirements and industry best practices, such as Design Control (per FDA regulations) and Design History File (DHF) maintenance
  • Labelling and packaging compliance
  • Post-market surveillance (PMS)
  • Complaint handling and medical device reporting
  • Conducting internal audits and preparing for regulatory inspections to ensure compliance with applicable regulations and standards
  • Providing ongoing training and education as subject matter experts to employees to ensure awareness and understanding of regulatory requirements and quality standards
  • Software as a Medical Device (SaMD) regulations
  • Unique Device Identification (UDI)
  • Ensuring compliance with regulatory requirements in multiple jurisdictions, including navigating differences in regulations between countries or regions

See the three ways we can help you to find a consultant →

Speak to us about your project requirements  →

See our current MedTech vacancies →

Learn more about elemed and our team of diagnostic and medical device consultant recruitment experts →

What types of company can your consultants support?

elemed has an extensive network of consultants within our community, many of whom have decades of experience working with MedTech companies.

Some of companies we have provided consultants for include:

  • Global MedTech corporations
  • Medical device and IVD manufacturers
  • High growth MedTech startups
  • Notified Bodies
  • Consultancies
  • Contact research organisations

     

Our team of talent management experts spend every day working with medical device and IVD consultants and companies, giving them an extensive knowledge of the complexities and nuances of medical and diagnostic devices. We know MDR from IVDR and understand the specific details between regulatory affairs, quality assurance and clinical affairs. We specialise in various areas of MedTech, allowing us to offer highly qualified consultants with the specific skills and experience required for your project. We have consultants available to work in the following locations:

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

What MedTech experience do your consultants have?

Our network of consultants includes experts across all functions and specialisms. Since being founded in 2015, our network and community of MedTech consultants in the medical device and diagnostics industry has grown and grown. We now work with some of the most exceptional consultants and contractors in the industry who are ready and available to support your project right now. We can source fantastic consultants for companies who are looking for support with compliance projects and need someone to start quickly

Other areas of support that 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 product types and specialisms do your MedTech consultants cover?

    • 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 should I use elemed to find a consultant?

Our network of expert consultants is second to none. The elemed talent management team has deep knowledge of the various MedTech skillsets and specialisms, meaning we really understand the projects we recruit for and what make our consultants ideal for them. 

What’s more, when you work with elemed we aim to deliver a shortlist of great MedTech consultants within 48 hours with a view to someone starting work with you within 10 days. We’re also much more cost-effective than traditional MedTech consulting alternatives!

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