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

About Katarzyna: A great auditor with extensive knowledge and vast experience that he can use in practice.

Elzbieta Olszewska

Lead Auditor, BSI

The period I worked together with Katarzyna for Helvoet and Partner was really a pleasure. She is an open minded and driven Plant Manager and also driving continuous improvement throughout the organization. She is extremely professional in supporting her customers, hard working and striving for results and win-win situations.

Johan Hye

Quality Manager, Helvoet

I've recently completed an ISO 9001 training course specifically designed for quality managers. The course was incredibly insightful and provided me with a deeper understanding of the standard's requirements and best practices.

One of the most valuable aspects of the training was the focus on practical application. The course also helped me to develop a strong understanding of the risk-based thinking approach that underpins ISO 9001.

I would highly recommend this course to any quality manager looking to enhance their skills and knowledge. The training has already had a positive impact on my role, and I'm confident that it will continue to benefit me in the future.

Patricia Johnson

Quality Manager, MoldTekton

Okay, so, mentoring programs about quality in design and dev, are seriously game-changing. You're not just memorizing stuff; you're actually doing it, learning the real-world quality hacks, problem-solving like a pro, and figuring out how to avoid epic fails before they happen. Contact with mentors from the first moment is natural and empathetic.

Rachel Richardson

Engineering Student

These mentors aren't just textbooks; they're your network, your connection to internships, jobs, the whole shebang. They get you, they guide you, and they help you figure out what you're even good at. Honestly, it's the ultimate career boost.

Marianna Mikulska

Biotechnology Student

I recently completed an ISO 9001 internal auditors training course together with 3-months mentoring program, and it was a total game-changer for my career. Not only did I learn the ins and outs of the standard, but I also got hands-on experience and personalized guidance from a experienced auditor.

The training was informative, covering everything from the basics of ISO 9001 to advanced auditing techniques. I especially appreciated the focus on practical application, as it helped me understand how to use the standard in real-world situations.

The mentoring aspect was the real icing on the cake. My mentor was knowledgeable and supportive.

Earl Hamilton

Quality Engineer, PolyChromatic Dynamics

Date, Language, Location

Your Training, Your Way

Date Language Location
20 – 21 January 2025 English Online
23 – 24 January 2025 Polish Cracow, Poland
05 – 06 February 2025 Polish Online
17 – 18 February 2025 English Birmingham, UK
28 – 29 April 2025 Polish Online
19 – 20 May 2025 English Online
02 – 03 June 2025 Polish Warsaw, Poland
04 – 05 June 2025 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! Enjoy FREE support and consultation for up to 3 months. We've got your back as you crush your goals.

FREE RESOURCES

Level up your game with exclusive access to our treasure trove of resources! Finish the training and unlock a world of workbooks, case studies, templates, and ebooks. It's like having a cheat sheet to success!

REWARDS FOR QUIZ WHIZ!

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