Join the thousands of medical device professionals who have benefitted from our expert-led courses, practical templates, and insightful learning resources.
Gain the clarity, confidence and skills needed to navigate complex regulatory requirements and bring medical devices to market more easily.
Our courses are developed by members of the standardization committees, giving you first-hand, up to date knowledge.
Learn straight from the experts who write and shape the ISO and IEC standards.
Our courses don’t just explain the requirements – they show you how to apply them effectively.
Learn practical strategies to understand, implement and stay compliant with confidence.
Our online courses consist of high-quality videos and quizzes broken into bite sized topics that can be repeated as needed.
Learn at your own pace and to suit your schedule.
Our courses have been accredited by the CPD Standards Office.
Upon completion of any of our courses, you will receive a certificate awarding you CPD points to go towards your professional development and to satisy ISO 13485 requirements.
Our state-of-the-art blended courses combine self-paced online learning with two instructor-led live virtual classroom sessions. Learn the theory first and then apply it through practical case studies and real-world scenarios. Free templates included plus plenty of time for Q&A with an industry expert.
Learn how to develop new medical devices and maintain them in organisations where design control requirements apply.
The course covers both European and US requirements.
Course length approx. 16-31 hours
Participant limit 8
Learn how to efficiently manage a medical device product development project. Gain hands-on tools and techniques for developing a medical device within budget and schedule constraints.
Course length approx. 17-34 hours
Participant limit 8
Learn how to work with risk management according to the ISO 14971:2019 standard. It also includes an orientation on the ISO 14971 risk management’s relation to tools and techniques such as FMEA and P-FMEA.
Course length approx. 13-23 hours
Participant limit 8
Learn how to identify and manage product specific requirements and how this process is integrated with the design control and risk management processes. The course covers the IEC 60601 series of standards.
The course is focused on the process of developing software for medical devices. It covers the IEC 62304 standard itself and in relation to other standards such as ISO 14971, IEC 60601-1 and IEC 82304-1.
The course covers topics of general requirements of usability engineering, use specification, establishing user interface specification and evaluation plan, user interface design, and performing formative and summative evaluations.
Our high-quality, self-managed, online courses can be completed in your own time. They are made up of carefully scripted pre-recorded videos, interactive quizzes, a downloadable course companion, and a final exam to maximize your learning. You can ask the instructors questions, and you can pause, resume, and repeat anytime, within the minimum 6 months of course access.
Learn how to develop new medical devices and maintain them in organisations where design control requirements apply. The course covers both European and US requirements.
€ 399
Learn how to establish a pragmatic usability engineering process that enables regulatory clearance and great product design during this self-paced, interactive online course.
€ 399
Learn how to plan and document software development with the course covering IEC 62304 and IEC 82304-1 regulatory requirements, cybersecurity management, cloud and AI.
€ 499
This online course focuses on identifying and managing applicable safety releated requirements throughout the design control process.
€ 449
Course focused on how to work with risk management according to the requirements of ISO 14971:2019 standard.
€ 399
Learn how to be effective in medical device software development with IEC 62304 standard, and apply it to your projects.
€ 449
Special launch offer: 349 299 EUR for the online plan & 449 349 EUR for the online lifetime plan.