Medical Device Regulatory Affairs Consultants

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Medical Device
Regulatory Affairs
Consultant

Fast. Agile. Staffing

elemed is a total talent management agency specialising in services and solutions tailored to the medical device industry, with a specialised focus on regulatory affairs. We support companies’ regulatory affairs compliance projects by sourcing consultants who are experts in their field. Leveraging over five decades of collective expertise, our team at elemed collaborates closely with seasoned consultants globally. We excel in sourcing consultants with extensive experience in regulatory affairs specific to medical devices, facilitating seamless compliance projects for companies of all sizes. This experience includes:

  • Regulatory strategy development
  • Regulatory intelligence
  • Preparation and submission of regulatory applications, such as 510(k), premarket approval (PMA), CE marking applications, and Investigational Device Exemption (IDE) applications
  • Clinical trial regulations
  • Quality management systems (QMS) implementation and maintenance 
  • Quality assurance
  • Post-market surveillance (PMS) and vigilance
  • Labelling compliance
  • Quality and manufacturing compliance
  • Submission of post-market reports, such as Medical Device Reports (MDRs) in the U.S. and Field Safety Corrective Actions (FSCAs) in Europe
  • International regulatory compliance
  • Regulatory compliance audits
  • Device classification and determining the appropriate regulatory pathway based
  • Regulatory due diligence

     

Explore our solutions for delivering exceptional RA consultants  →

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How does elemed source the best medical device regulatory affairs consultants?

elemed has a highly reputable network of experienced MedTech consultants, including numerous specialists in medical devices and regulatory affairs who are renowned for their expertise. Our total talent management team is committed to understanding your requirements and delivering a fantastic shortlist of consultants who are selected precisely to meet your project needs within 48 hours of your initial inquiry.  Our efficient process also ensures that your chosen consultant can begin work within an average of 10 days from our first conversation, guaranteeing a swift project commencement and mitigating any potential setbacks.

We have collaborated with a variety of businesses in search of consultants specialising in medical device regulatory affairs, including:

  • Large global corporations
  • Medical device manufacturers
  • Emerging medical device startups
  • Notified Bodies
  • Consulting firms
  • Contract research organisations

     

With over 50 years of collective experience, our team collaborates closely with RA consultants and medical device companies on a daily basis, giving us comprehensive insights into the intricacies of regulatory compliance and what a great set of skills and experience looks like. We work with outstanding consultants who are recognised subject matter experts in medical devices and regulatory affairs, poised to aid your business in navigating regulations, ensuring quality, and achieving compliance. Our assistance is accessible to companies worldwide, spanning diverse geographical regions such as:

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

What expertise do elemed's consultants have?

The consultants we work with possess diverse skills and experiences relating to medical devices and regulatory, which means that whatever your requirements are, we can match you the ideal candidate to meet your project needs. Consultants offer flexible support tailored to your project’s timeline and duration. Additionally, our consultants are poised to start work quickly, with the majority typically starting within approximately 10 days of your initial engagement with us.

Other areas of support 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 areas does elemed specialise 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

Why should I work with regulatory consultant via elemed?

We partner with a wide range of esteemed consultants who are experts in regulatory affairs for medical devices. They bring extensive expertise in MDR, IVDR, FDA, global regulatory strategy, technical documentation, design control, risk management, device registration, handling feedback from competent authorities and notified bodies, and much more.

On average, we provide a carefully selected shortlist of exceptional regulatory consultants within just 48 hours, with an average ratio of 3 CVs to 1 placed consultant. Plus, our services offer a more cost-effective solution compared to traditional regulatory consultancy services.

medical device regulatory affairs consultant

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