ISO 14971 Requirements Training Course

What will you gain with this training?

  • Deep understanding of ISO 14971: Learn how to apply risk management to medical devices in compliance with ISO 14971 requirements.
  • Risk assessment and mitigation skills: Master the tools and techniques to identify, evaluate, and control risks associated with medical devices.
  • Improved compliance: Ensure that your organization meets regulatory expectations for medical device safety and risk management.
  • Practical application: Gain experience with real-world case studies, ensuring you can implement ISO 14971 processes.

Who should attend?

  • Medical Device Engineers and Designers – To ensure risk management practices are embedded throughout the device development lifecycle.
  • Quality Assurance and Regulatory Affairs Professionals – To maintain compliance with ISO 14971 and ensure safety standards are met.
  • Risk Management Teams – To develop a deep understanding of risk assessment techniques specific to medical device development.
  • Project Managers – To oversee the integration of risk management processes into medical device design and development projects.
  • Compliance Officers – To ensure medical device risk management meets ISO and regulatory standards.

Requirements Training Course ISO 14971

Level: Understanding

Duration: 1 day

Available: Online Training, On-Site Training

From £980 + VAT
View dates and book

Available: On-demand eLearning

Check Details

Available to quote: In-house

Request a quote

Do you expect boring training with lots of talking?

No way! We have games and funny sketchnotes.

No more boring lectures! This ISO 14971 training is interactive and engaging, featuring:

  • Clear and concise explanations: We’ll break down ISO 14971 requirements using simple language and real-world medical device scenarios.
  • Hands-on exercises: Practice applying risk management principles directly to your projects, ensuring compliance with ISO 14971.
  • Q&A sessions: Ask questions and get expert answers from experienced trainers who specialize in medical device risk management.

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

  • Understand the key principles of ISO 14971 and how to apply them to medical device development.
  • Conduct thorough risk assessments and create mitigation plans.
  • Ensure compliance with global regulations for medical device risk management.

Don’t miss this opportunity to master ISO 14971 and bring a higher level of safety and compliance to your medical devices!

Don’t Buy Beautiful Promises

Get a taste of the training.

You Will Learn

  • Understand the core principles of ISO 14971 and how they apply to medical device risk management.
  • Conduct comprehensive risk assessments for medical devices, identifying potential hazards.
  • Develop effective risk control measures to minimize risks and ensure device safety.
  • Maintain compliance with international regulations by integrating ISO 14971 into the medical device development lifecycle.

You Will Practice

  • Applying ISO 14971 risk management processes to a case study of a medical device in development.
  • Conducting hazard identification and risk analysis using real-world examples from the medical device industry.
  • Creating risk mitigation strategies for identified risks during the case study.
  • Collaborating with cross-functional teams to integrate risk management into the entire product lifecycle.

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

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!

Ready to flex your brain? Crush our challenges and win awesome prizes. Level up your knowledge and climb the leaderboard. Top scorers get exclusive rewards!

Date, Language, Location

Your Training, Your Way

Date Language Location
21 January 2025 English Birmingham, UK
19 February 2025 English Online
11 April 2025 Polish Cracow, Poland
25 April 2025 Polish Online

£980.00

Training Courses

Explore our training courses and mentoring programs

Everyone's got their own learning style, right? Some people are all about hands-on stuff, while others prefer to chill and soak it all in. That's why we've cooked up a bunch of different ways to learn. No one-size-fits-all here!

You and your team will all learn in different ways, so we’ve devised a range of flexible delivery formats to suit all needs. 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 help you level up your skills and crush your goals.