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 in risk management, design control, project management, quality management, software development, usability engineering, and safety for medical devices.

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Take the hassle out of medical device product development

We provide world-class training that enables you to put theory into practice using real life scenarios and case studies. Our training also includes user-friendly templates, checklists and reference materials to make your life easier. And our courses are both fun and engaging!

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Know what is enough from a regulatory point-of-view

We will show you how regulatory processes and best practices can help you be effective. Our lean and pragmatic approach means that you won’t end up overdoing things from a regulatory point of you. By the end of the course, you will not only understand the principles of medical device product development better, but you will believe in them.

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Take the next step in you career

You can become a medical device guru amongst your colleagues. You will not only understand the big picture but also the details behind it. You will understand industry language better which will help avoid miscommunication and reduce frustration. And, the certificate you will receive at the end of the course will prove your competence with auditors! All of this can help further your career.

Blended courses (online + live virtual class)

Our state of the art blended courses combine online training with a live virtual classroom session, 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.

DESIGN CONTROL
ONLINE + LIVE VIRTUAL CLASS

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

PROJECT MANAGEMENT
ONLINE + LIVE VIRTUAL CLASS

Project Management for Product
Development of Medical Devices

Course covering the best practices when developing new medical devices and maintain 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

RISK MANAGEMENT
ONLINE + LIVE VIRTUAL CLASS

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

SAFETY FOR ELECTRICAL MEDICAL DEVICES
ONLINE + LIVE VIRTUAL CLASS

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. 17-22 hours
Participant limit 8

MEDICAL SOFTWARE DEVELOPMENT
ONLINE + LIVE VIRTUAL CLASS

Software for Medical Devices and IEC 62304

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. 22-32 hours
Participant limit 8

Usability Engineering and IEC 62366-1 UE2B blended course

USABILITY
ENGINEERING
ONLINE + LIVE VIRTUAL CLASS

Usability Engineering for Medical Devices and IEC 62366-1

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.

Course length approx 22-32 hours
Max number of participants 8

View all Blended Courses

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.

View all Templates

Articles

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

View all Articles

Online courses

Our high quality, self-managed, on-line 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, an Introduction to Working in the Medical Device Industry and Project Management.

Introduction to design control for medical devices feature image

Introduction to Design Control
for Medical Devices
(online)

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 62366-1:2020 online course

Introduction to Usability Engineering and IEC 62366-1
(online)

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 8-16 hours

€ 399

Introduction to Safety for Electrical
Medical Devices and IEC 60601
(online)

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 feature image

Introduction to Risk Management for Medical Devices and ISO 14971:2019 (online)

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 Design Control for Medical Devices

Introduction to Software for
Medical Devices and IEC 62304
(online)

Learn how to be effective in medical software development according to the process of the IEC 62304.

Course Length 15-25 hours

€ 449

Introduction to Working in the Medical Device Industry - Online course feature image

Introduction to Working in Medical Device Industry
(Online)

Prepare yourself for working in the medical device industry with this introductory, self-paced online course.

Course Length 3-6 hours

€ 99

View all Courses

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