ISO 13485 Requirements Training Course

What will you gain with this training?

  • In-depth knowledge of ISO 13485: Learn how to implement and maintain a quality management system specific to the medical device industry.
  • Enhanced regulatory compliance: Understand how to meet global regulatory requirements for medical devices, ensuring product safety and quality.
  • Process improvement strategies: Gain tools to improve product development, risk management, and overall quality in medical device manufacturing.
  • Hands-on experience: Apply ISO 13485 requirements to real-world scenarios, preparing you to implement best practices in your organization.

Who should attend?

  • Medical Device Manufacturers – To ensure their products meet ISO 13485 standards for quality and regulatory compliance.
  • Quality and Regulatory Affairs Professionals – To oversee and maintain ISO 13485-compliant quality management systems.
  • Design and Development Engineers – To incorporate ISO 13485 requirements into the medical device design and development process.
  • Compliance Officers and Auditors – To ensure that all aspects of medical device production and management are compliant with ISO 13485.
  • Project Managers – To manage medical device projects aligned with ISO 13485 requirements and maintain consistent product quality.

Requirements Training Course ISO 13485

Level: Understanding

Duration: 2 days

Available: Online Training, On-Site Training

From £1390 + VAT
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Available: On-demand eLearning

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Available to quote: In-house

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Do you expect boring training with lots of talking?

No way! We have games and funny sketchnotes.

No more boring lectures! This ISO 13485 training is interactive and engaging, featuring:

  • Clear and concise explanations: We’ll simplify ISO 13485 requirements using real-world medical device industry examples.
  • Hands-on exercises: Practice applying ISO 13485 principles to your processes, ensuring your products meet quality and regulatory standards.
  • Q&A sessions: Ask questions and receive expert insights from experienced trainers with real industry knowledge.

By the end of this training, you’ll be equipped to:

  • Understand the core principles of ISO 13485 and how they apply to your quality management system.
  • Implement ISO 13485 requirements to improve product safety and regulatory compliance.
  • Enhance your processes to meet the latest medical device industry standards.

Don’t miss this opportunity to master ISO 13485 and take your medical device quality to the next level!

Don’t Buy Beautiful Promises

Get a taste of the training.

You Will Learn

  • Understand and apply ISO 13485 requirements to create and maintain a compliant quality management system for medical devices.
  • Ensure regulatory compliance with global medical device regulations through ISO 13485 implementation.
  • Manage risk effectively within medical device design, manufacturing, and post-production processes.
  • Improve product development and quality processes to enhance product safety and effectiveness.

You Will Practice

  • Applying ISO 13485 principles in a hands-on case study, simulating real-life medical device development and production scenarios.
  • Conducting risk assessments and identifying corrective actions to ensure compliance with ISO 13485 standards.
  • Performing internal audits based on ISO 13485 requirements to identify gaps and areas for improvement.
  • Collaborating in teams to develop an action plan for implementing and maintaining ISO 13485 compliance in their organization.

You Will Have Fun

  • Playing educational games
  • Using our amusing skechnotes
  • Completing interactive tasks

Date, Language, Location

Your Training, Your Way

Date Language Location
19 – 2o January 2026 English Online
22 – 23 January 2026 Polish Cracow, Poland
04 – 05 February 2026 Polish Online
16 – 17 February 2026 English Birmingham, UK
27 – 28 April 2026 Polish Online
18 – 19 May 2026 English Online
01 – 02 June 2026 Polish Warsaw, Poland
03 – 04 June 2026 English Birmingham, UK

£1,390.00

Can this training get any better?

Yes! Now your jaw will drop.

FREE POST-TRAINIG SUPPORT

Not sure how to apply what you learned? Don't sweat it! To ensure your success, you can enjoy FREE support and consultation for up to 3 months. In other words, we’ve got your back as you work to crush your goals. Furthermore, this dedicated support period means you’ll never have to tackle complex challenges alone.

FREE RESOURCES

Level up your game with exclusive access to our treasure trove of resources! As soon as you finish the training, you will unlock a world of workbooks, case studies, templates, and ebooks. In fact, it’s like having a permanent cheat sheet to success! Furthermore, these tools are designed to help you use your new skills immediately. As a result, you’ll be able to move from learning to high-impact action without any guesswork.

REWARDS FOR QUIZ WHIZ!

Ready to flex your brain? To get started, you can take on our challenges and win awesome prizes. By doing so, you will level up your knowledge while at the same time climbing the leaderboard. Moreover, the competition doesn’t end there; specifically, our top scorers receive exclusive rewards as a tribute to their expertise. Ultimately, every challenge you complete brings you one step closer to the top of the pack!

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In the same way, we know that you and your team will all learn differently. Consequently, we’ve devised a range of flexible delivery formats to suit every possible need. Specifically, whether you're a night owl, an early bird, or somewhere in between, we've got you covered. From in-person hangouts to online adventures, we'll ultimately help you level up your skills and crush your goals.