Sustainability consultants

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Medical Device
Sustainability
Consultant

Fast. Agile. Staffing

elemed is a comprehensive MedTech total talent management agency specialising in services and solutions tailored for the medical device and diagnostic industry, with a particular emphasis on medical device sustainability initiatives. We assist sustainability-focused companies in finding exceptional consultants who possess extensive experience in compliance. With a wealth of expertise spanning over five decades, the elemed team collaborates closely with talented consultants worldwide. We boast a market-leading network of sustainability consultants with diverse backgrounds in regulatory affairs, quality assurance, clinical trials, digital health, artificial intelligence (AI), and cybersecurity, all geared towards advancing sustainability goals. This means that when you approach us with your sustainability project, we can promptly connect you with top-notch consultants to propel your sustainability initiatives toward successful realisation.

Our consultants have experience with:

  1. Lifecycle Assessment (LCA): Consultants can conduct comprehensive LCAs to assess the environmental impact of medical devices throughout their entire lifecycle, from raw material extraction to disposal or recycling. This assessment helps identify areas for improvement in sustainability practices.

  2. Material Selection and Sourcing: Consultants can advise on sustainable material choices for medical devices, considering factors such as biodegradability, recyclability, and environmental impact. They can also help establish sustainable sourcing practices to ensure responsible procurement of materials.

  3. Design for Environment (DfE): Consultants can assist in implementing DfE principles to optimize the environmental performance of medical device designs. This includes reducing material usage, minimizing energy consumption during manufacturing, and enhancing end-of-life recyclability.

  4. Energy Efficiency: Consultants can evaluate energy usage throughout the manufacturing process and recommend strategies to improve energy efficiency. This may involve optimizing manufacturing processes, upgrading equipment for energy savings, or implementing renewable energy sources.

  5. Waste Reduction and Management: Consultants can develop waste reduction strategies and help implement effective waste management practices within medical device manufacturing facilities. This includes recycling initiatives, waste minimization programs, and proper disposal of hazardous materials.

  6. Supply Chain Sustainability: Consultants can work with medical device manufacturers to assess the sustainability of their supply chains, identifying opportunities to reduce carbon footprint, improve ethical sourcing practices, and enhance social responsibility.

  7. Regulatory Compliance: Consultants can provide guidance on navigating complex regulatory requirements related to environmental sustainability in the medical device industry. This ensures that companies remain compliant with relevant environmental regulations and standards.

  8. Carbon Footprint Assessment: Consultants can conduct carbon footprint assessments to quantify the greenhouse gas emissions associated with medical device manufacturing processes. This data can inform emission reduction strategies and support efforts to achieve carbon neutrality.

  9. Stakeholder Engagement: Consultants can facilitate stakeholder engagement initiatives to foster collaboration and communication among various stakeholders, including suppliers, customers, regulatory agencies, and advocacy groups, to promote sustainability goals within the medical device industry.

  10. Continuous Improvement: Consultants can support continuous improvement efforts by helping companies establish key performance indicators (KPIs) for sustainability, tracking progress against targets, and implementing strategies to continuously enhance sustainability performance.
     

Find out more about how we source fantastic sustainability consultants and how they can support your projects →

Talk to us about your sustainability requirements

Learn more about elemed, total talent management and what makes us difference→

How does elemed find its consulants?

elemed proudly maintains an extensive network of industry-leading sustainability consultants, including numerous experts renowned for their depth of knowledge and experience. Our dedicated talent management team is committed to comprehensively understanding your sustainability project requirements and curating an exceptional shortlist of consultants precisely tailored to your needs, all within a swift 48-hour timeframe from your initial inquiry. Furthermore, our streamlined process ensures that your selected consultant can commence work within an average of just 10 days from our initial conversation, facilitating a prompt project kickoff and reducing the chance potential delays.

We  work with a variety of businesses seeking consultants specialised in sustainability, 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 total talent management team collaborates closely with consultants and sustainability-focused companies on a daily basis, meaning we have a deep knowledge of the intricacies of sustainability and the skills and experience needed to achieve and maintain it. We collaborate with exceptional consultants recognized as subject matter experts across regulatory affairs, quality assurance, environmental impact assessment, sustainable practices, renewable energy, and more for sustainability, who are available to start work on your project right now. Our support extends globally, encompassing diverse geographical regions including:

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

What skills and experience do your sustainability consultants have?

The consultants within our network bring a broad spectrum of sustainability skills and experience, ensuring that we can find the perfect candidate to meet your project needs, no matter how specific or niche they may be. Our consultants provide flexible support tailored to your project’s timeline and duration. Moreover, our consultants are ready to hit the ground running, with most commencing work within about 10 days of your initial engagement with us.

Aeas our consultants can support with:

  • 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 other areas do elemed's consultants 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 work with an elemed sustainability consultant?

We collaborate with renowned consultants who are authorities in sustainability. They are proficient in global sustainability regulations and requirements including environmental impact assessment, sustainable practices, renewable energy, waste management, carbon footprint reduction, ethical sourcing, and many other areas.

We typically share a curated shortlist of excellent consultants within 48 hours of speaking, maintaining an average ratio of 3 CVs to 1 placed consultant. Moreover, our services provide a more cost-effective solution compared to conventional options in sustainability consulting.

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