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Medical devices and IVDs

Custom training courses

Our custom courses are developed in close collaboration with your organization. We adapt the scope, depth, format, and examples to match your products, processes, and regulatory context.

Custom training for your organization

Custom expert-led training courses

Every organization faces unique regulatory, quality, and clinical research challenges. Aurevia offers custom-designed training tailored to your organization’s needs—whether you are preparing for MDR or IVDR compliance, strengthening your quality management system, building robust technical documentation, or developing clinical evidence strategies.

Our custom courses are developed in close collaboration with your organization. We adapt the scope, depth, format, and examples to match your products, processes, level of understanding, and regulatory context.

Training can be delivered:

  • On-site or online
  • As short workshops or multi-day programs
  • For specific roles or cross-functional teams

All courses are grounded in current regulatory requirements, guidance, and best practices—combined with real‑world implementation experience.

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Topics

Our custom training courses can cover a wide range of topics, including but not limited to:

  • MDR & IVDR compliance and regulatory strategy

  • Technical documentation

  • Risk management (ISO 14971)

  • Quality Management Systems (i.e., ISO 13485, FDA QMSR, ISO 15189)

  • Clinical research

  • Clinical evaluation and clinical evidence strategies

  • Post‑market surveillance and vigilance

  • Usability engineering

  • Supplier and software compliance

  • Cybersecurity

  • Audits, inspections, and readiness activities

If you have a specific challenge or topic in mind, we tailor the content to match your needs and objectives.

Target group

Custom courses are suitable for professionals across functions and experience levels, including:

    • Quality Assurance & Regulatory Affairs
    • Clinical Affairs & Medical Affairs
    • R&D and Engineering
    • Product Management
    • Management teams preparing for regulatory change or audits
    • Cross‑functional project teams

The training level can be adjusted for beginners, experienced professionals, or mixed audiences.

 

Objectives

Depending on your selected topics, participants will:

    • Gain practical understanding of applicable regulations and standards
    • Learn how requirements apply to your organization’s products and processes
    • Understand common pitfalls and how to avoid them
    • Strengthen internal collaboration across functions
    • Leave with concrete takeaways that support compliant and efficient implementation

 

Training that builds confidence in compliance

Our custom courses are designed and delivered by experienced consultants with deep hands-on expertise across the medtech, healthtech and life science landscape. 

  • Tailored content based on your real challenges
  • Trainers with hands-on regulatory and compliance experience
  • Up‑to‑date interpretation of MDR, IVDR, and international standards
  • Practical focus—beyond theory and checklists

Our training sessions are tailored, practical, and grounded in real-world regulatory experience. We’ve had the privilege of training not only industry professionals but also regulatory authorities—such as the Swedish Medical Products Agency (Läkemedelsverket). Whether you're strengthening your internal capabilities, preparing for an audit, or launching a new product, we’re here to help you stay ahead.

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Assured solutions

We deliver agile, tailored solutions through deep expertise and a commitment to excellence.