Training courses, templates & coaching for professionals working within the medical device industry

Become more confident in medical device product development. Join thousands of medical device professionals that take our highly-rated public and customised blended (online + live virtual class), classroom and online courses. Topics include risk management, design control, project management, quality management, software development, usability engineering, safety for medical devices, clinical investigation and the Medical Device Regulation.

 

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Direct access to authors of the standards

Our courses are developed by members of the standardization committees, ensuring you receive up to the minute, first-hand information. Gain insights by learning from those who author the standards.

Training effectiveness and record-keeping

We measure our training’s effectiveness by assessing participants' knowledge throughout the course. We provide records, including course certificates to satisfy ISO 13485 requirements.

Emphasis on implementation of requirements

Our courses go beyond explaining requirements. We guide you to implement them effectively.
Understand and meet requirements with practical strategies.

Blended courses (online + live virtual class)

Our state of the art blended courses combine online training with live virtual classroom sessions, led by an industry expert. This way, the theory is learnt first at your own pace, before being put into practice, using case studies and real-life scenarios, during the classroom session. The online training can be started immediately. We currently offer this type of course for Design Control for Medical Devices, Project Management for Product Development of Medical Devices, Risk Management for Medical Devices, Safety for Electrical Medical Devices, Medical Software Development, and Usability Engineering.

blended course design control for medical devices​

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. 17-27 hours
Participant limit 8
blended course project management for product development of medical devices

The course covers best practices when developing new medical devices and maintaining them in organisations where design control requirements apply. The course covers both European and US requirements.

Course length approx. 22-27 hours
Participant limit 8
blended course risk management for medical devices and iso 14971:2019

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. 17-27 hours
Participant limit 8
blended course safety for electrical medical devices and iec 60601-1

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.

Course length approx. 17-27 hours
Participant limit 8
blended course usability engineering and iec 62366-1​

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.

Course length approx. 22-27 hours
Participant limit 8
blended course software for medical devices and iec 62304

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.

Course length approx. 17-27 hours
Participant limit 8

Templates

Click on the button to view the full range of our expertly crafted professional templates which will help you create the required documentation to meet ISO 13485 or QSR requirements.

Articles

Find fresh and useful information, tips and tricks regarding project management, product development and design control from professionals in the medical device industry.

Online courses

Our high quality, self-managed, online learning courses can be completed in your own time. You have access for 6 months and can pause, resume and repeat as many times as you like! The course consists of pre-recorded lessons, quizzes and a final exam. Upon completion, you will receive a course certificate for your training records. Currently available are courses in Design Control, Usability Engineering, Safety for Electrical Medical Devices, Risk Management, Software for Medical Devices, SAMD, Medical Device Regulation, Quality Management, Requirements Engineering, Introduction to Working in the Medical Device Industry and Project Management.

introduction to design control for medical devices

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 10-20 hours

€ 299

introduction to usability engineering and iec 62366-1

Learn how to establish a pragmatic usability engineering process that enables regulatory clearance and great product design during this self-paced, interactive online course.

Course length 18-16 hours

€ 399

introduction to samd iec 62304 and iec 82304-1

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.

Course length 15-25 hours

€ 449

introduction to safety for electrical medical devices and iec 60601-1

This online course focuses on identifying and managing applicable safety releated requirements throughout the design control process.

Course length 10-15 hours

€ 449

introduction to risk management for medical devices and iso 14971:2019

Course focused on how to work with risk management according to the requirements of ISO 14971:2019 standard.

Course length 10-20 hours

€ 299

introduction to software for medical devices and iec 62304

Learn how to be effective in medical device software development with IEC 62304 standard, and apply it to your projects.

Course length 15-25 hours

€ 449

How to Online courses

Our short courses focus on single topics and explain real-life scenarios and working with templates available on Medical Device HQ platform is a great way to introduce yourself to the flow and structure of our regular online courses. Currently available are the course on creating a Design and Development Plan, and course on creating a Risk Management Plan.

how to create a medical device design and development plan

Course focused on how to create a design and development plan based on a Medical Device HQ template and address the requirements in 7.3.2 in ISO 13485 and 820.30 in QSR.

Course length 1-2 hours

€ 49 Limited time free access

how to create a medical device​ risk management plan

Course focused on creating a medical device risk management plan that meets the requirements of ISO 14971:2019, MDR and QSR based on a free Medical Device HQ template.

Course length 1-2 hours

€ 49

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