--- title: "Home" description: "Training courses, templates & coaching for professionals working within the medical device industry. Design Control, Risk Management, MDR." url: "https://medicaldevicehq.com/" date_modified: "2026-06-18T11:43:55+02:00" --- ## Training courses, templates and learning resources for medical device professionals --- ### Trusted by companies, regulatory bodies, and individuals worldwide --- 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.   ![SIS Standard Developer 2025](https://medicaldevicehq.com/wp-content/uploads/2025/03/standardeveloper2025en.png) [Video](https://www.youtube.com/watch?v=gFcnGzOM5HY) - Topics include: - [Risk management](https://medicaldevicehq.com/training-courses/topic-risk-management/) - [Design control](https://medicaldevicehq.com/training-courses/topic-design-controls/) - [Software development](https://medicaldevicehq.com/training-courses/topic-software-development/) - [Quality management](https://medicaldevicehq.com/training-courses/topic-quality-management/) - [Safety for medical devices](https://medicaldevicehq.com/training-courses/topic-electrical-safety/) - [Process validation](https://medicaldevicehq.com/training-courses/topic-process-validation/) - [Internal auditing](https://medicaldevicehq.com/training-courses/topic-internal-auditing/) - [Requirements engineering](https://medicaldevicehq.com/training-courses/topic-requirements-engineering/) - [Clinical investigation](https://medicaldevicehq.com/training-courses/topic-clinical-investigation/) - [Usability engineering](https://medicaldevicehq.com/training-courses/topic-usability-engineering/) - [Medical device regulation](https://medicaldevicehq.com/training-courses/topic-medical-device-regulation/) - [Project management](https://medicaldevicehq.com/training-courses/topic-project-management/) --- [Video](https://www.youtube.com/watch?v=gFcnGzOM5HY) 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. **Topics include:** [risk management](https://medicaldevicehq.com/training-courses/topic-risk-management/), [design control](https://medicaldevicehq.com/training-courses/topic-design-controls/), [project management](https://medicaldevicehq.com/training-courses/topic-project-management/), [quality management](https://medicaldevicehq.com/training-courses/topic-quality-management/), [software development](https://medicaldevicehq.com/training-courses/topic-software-development/), [usability engineering](https://medicaldevicehq.com/training-courses/topic-usability-engineering/), [safety for medical devices](https://medicaldevicehq.com/training-courses/topic-electrical-safety/), [clinical investigation](https://medicaldevicehq.com/training-courses/topic-clinical-investigation/) and [the Medical Device Regulation](https://medicaldevicehq.com/training-courses/topic-medical-device-regulation/). ![SIS Standard Developer 2025](https://medicaldevicehq.com/wp-content/uploads/2025/03/standardeveloper2025en.png) --- ## Join 1000+ companies who trust Medical Device HQ --- ![SimplerQMS logo](https://medicaldevicehq.com/wp-content/uploads/2025/12/SimplerQMS.png) ![Agilent Technologies logo](https://medicaldevicehq.com/wp-content/uploads/2022/09/Agilent_Technologies.png) ![Alcon logo](https://medicaldevicehq.com/wp-content/uploads/2022/09/alcon.png) ![Ambu logo](https://medicaldevicehq.com/wp-content/uploads/2022/09/Ambu.png) ![Bio SB logo](https://medicaldevicehq.com/wp-content/uploads/2022/09/biosb.jpg) ![Boston Scientific logo](https://medicaldevicehq.com/wp-content/uploads/2022/09/Boston_Scientific.png) ![coloplast logo](https://medicaldevicehq.com/wp-content/uploads/2022/09/coloplast.png) ![Cook Medical logo](https://medicaldevicehq.com/wp-content/uploads/2022/09/Cook-Medical.jpg) ![Cortex logo](https://medicaldevicehq.com/wp-content/uploads/2022/09/cortex.png) ![Deloitte logo](https://medicaldevicehq.com/wp-content/uploads/2022/09/Deloitte.png) ![Demant logo](https://medicaldevicehq.com/wp-content/uploads/2022/09/Demant.png) ![Design Psychology logo](https://medicaldevicehq.com/wp-content/uploads/2022/09/DPsy.png) ![doctrin logo](https://medicaldevicehq.com/wp-content/uploads/2022/09/doctrin.png) ![ELOS Medtech logo](https://medicaldevicehq.com/wp-content/uploads/2022/09/elos-medtech.png) ![Endomag logo](https://medicaldevicehq.com/wp-content/uploads/2022/09/Endomag.png) ![ferrosan logo](https://medicaldevicehq.com/wp-content/uploads/2022/09/ferrosan.png) ![ReSound logo](https://medicaldevicehq.com/wp-content/uploads/2022/09/ReSound.png) ![Greenlight Guru logo](https://medicaldevicehq.com/wp-content/uploads/2022/09/greenlight-guru.png) ![Handicare logo](https://medicaldevicehq.com/wp-content/uploads/2022/09/Handicare-logo.jpg) ![Hemocue logo](https://medicaldevicehq.com/wp-content/uploads/2022/09/hemocue.png) ![Huma logo](https://medicaldevicehq.com/wp-content/uploads/2022/09/Huma.jpg) ![ICONOVO logo](https://medicaldevicehq.com/wp-content/uploads/2022/09/ICONOVO.png) ![Immunovia logo](https://medicaldevicehq.com/wp-content/uploads/2022/09/Immunovia.jpg) ![Lifenet logo](https://medicaldevicehq.com/wp-content/uploads/2022/09/lifenet.png) ![LiNA logo](https://medicaldevicehq.com/wp-content/uploads/2022/09/LiNA.jpg) ![Medtrace logo](https://medicaldevicehq.com/wp-content/uploads/2022/09/medtrace.png) ![Norway Health Tech logo](https://medicaldevicehq.com/wp-content/uploads/2022/09/norway-health-tech.png) ![Ohio Medical logo](https://medicaldevicehq.com/wp-content/uploads/2022/09/ohio-medical.png) ![oticon logo](https://medicaldevicehq.com/wp-content/uploads/2022/09/oticon.png) ![PMD_Solutions logo](https://medicaldevicehq.com/wp-content/uploads/2022/09/PMD_Solutions.jpg) ![Radiometer logo](https://medicaldevicehq.com/wp-content/uploads/2022/09/Radiometer.png) ![RSP logo](https://medicaldevicehq.com/wp-content/uploads/2022/09/RSP.png) ![SHL healthcare logo](https://medicaldevicehq.com/wp-content/uploads/2022/09/shl-healthcare.png) ![StrechCare logo](https://medicaldevicehq.com/wp-content/uploads/2022/09/strechcare.jpg) ![Uneegmedical logo](https://medicaldevicehq.com/wp-content/uploads/2022/09/uneegmedical.png) ![3shape logo](https://medicaldevicehq.com/wp-content/uploads/2022/09/3shape.png) --- ##### Created by authors of the ISO & IEC standards 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. ##### Focused on practical implementation Our courses don’t just explain the requirements – they show you how to apply them effectively. Learn practical strategies to implement and help you stay compliant with confidence ##### Self-paced and bite-sized learning 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. --- ![freepik__adult-50-yo-female-white-shirt-glasses-holding-tab__84663 1](https://medicaldevicehq.com/wp-content/uploads/2025/08/freepik__adult-50-yo-female-white-shirt-glasses-holding-tab__84663-1.png) ![Group 685](https://medicaldevicehq.com/wp-content/uploads/2025/08/Group-685.png) ##### CPDSO-accredited training courses 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.  --- ### Whether you prefer online courses, classroom sessions, blended learning or tailored in-house solutions, we can be flexible to meet your needs. --- [Contact us for tailored in-house training](#elementor-action%3Aaction%3Dpopup%3Aopen%26settings%3DeyJpZCI6IjM0MjAxNyIsInRvZ2dsZSI6ZmFsc2V9) --- ## Blended courses (online + 2 classroom sessions) 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. ![blended course design control for medical devices​](https://medicaldevicehq.com/wp-content/uploads/2024/02/DC2B-Design-control-for-medical-devices​-practitioner-training.jpg)  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 ![blended course project management for product development of medical devices](https://medicaldevicehq.com/wp-content/uploads/2024/02/PMMDD2B-Project-management-for-product-development-of-medical-devices​-practitioner-training.jpg) 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 ![Risk-management-for-medical-devices-and-iso-149712019-practitioner-training.jpg](https://medicaldevicehq.com/wp-content/uploads/2025/09/Risk-management-for-medical-devices-and-iso-149712019-practitioner-training.jpg) 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 ![blended course safety for electrical medical devices and iec 60601-1](https://medicaldevicehq.com/wp-content/uploads/2024/02/MEE2B-Safety-for-electrical​-medical-devices-and-iec-60601-1​-practitioner-training.jpg) 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. 16-32 hours **Participant limit** 8 ![blended course software for medical devices and iec 62304](https://medicaldevicehq.com/wp-content/uploads/2024/02/SW2B-Software-for-medical-devices-and-iec-62304​-practitioner-training.jpg) 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. 16-32 hours **Participant limit** 8 ![blended course usability engineering and iec 62366-1​](https://medicaldevicehq.com/wp-content/uploads/2024/02/UE2B-Usability-engineering-and-iec-62366-1​​-practitioner-training.jpg) 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. 9-24 hours **Participant limit** 8 [View all blended courses](/training-courses/course-type-blended-course/) --- ## 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](/templates/) ## Articles Find fresh and useful information, tips and tricks regarding project management, product development and design control from professionals in the medical device industry. [View all Articles](/articles/) --- ## Online courses 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. ![design control for medical devices online course](https://medicaldevicehq.com/wp-content/uploads/2024/01/DC1O-Design-control-for-medical-devices.jpg) 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 € 399 ![Introduction to Usability Engineering online course](https://medicaldevicehq.com/wp-content/uploads/2021/09/UE1O-Usability-engineering-and-iec-62366-1.jpg) 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 ** 8-22 hours € 399 ![SaMD, IEC 62304 and IEC 82304-1 online course](https://medicaldevicehq.com/wp-content/uploads/2022/10/SaMD1O-Samd-iec-62304-and-iec-82304-1.jpg) 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 **10-29 hours € 499 ![Introduction to Safety for Electrical Medical Devices and IEC 60601 online course feature image](https://medicaldevicehq.com/wp-content/uploads/2020/06/MEE1O-Safety-for-electrical​-medical-devices-and-iec-60601.jpg) This online course focuses on identifying and managing applicable safety releated requirements throughout the design control process. **Course length **9-25 hours € 449 ![risk management for medical devices and ISO 14971:2019 feature image](https://medicaldevicehq.com/wp-content/uploads/2020/07/RM1O-Risk-management-for-medical-devices-and-iso-14971.jpg) Course focused on how to work with risk management according to the requirements of ISO 14971:2019 standard. **Course length **6-16 hours € 399 ![Introduction to software for medical devices and IEC 62304 feature image](https://medicaldevicehq.com/wp-content/uploads/2020/07/SW1O-Software-for-medical-devices-and-iec-62304.jpg) Learn how to be effective in medical device software development with IEC 62304 standard, and apply it to your projects. **Course length ** 9-25 hours € 449 [View all online courses](/training-courses/course-type-online-course/) --- I really liked the online course’s interactive format. The lessons were built up nicely and the slides were easy to understand and follow. The checkpoint questions helped a lot and to be able to repeat them and test myself again was awesome! Helen Therese KalfjøsQuality ManagerLuzmon Medical AS I thought the way it was delivered in bite-sized sections was perfect, none were too long but that did not mean the overall course was too long either. I think Peter does a great job explaining concepts and delivering the training in the video. Molly CalveyQuality Success ManagerQualio Peter is an excellent communicator who understands the audience and pitches what would otherwise be very dry content in the right way. The quizzes throughout are great for reinforcement. Rich ArnattHead of Product DevelopmentKinomica The course is brilliant – Peter Sebelius is an expert in this field, and it clearly shows, and his positive attitude and interest in the subject matter really “comes through the screen”. The course is filled with relevant and representative examples, and I think most people in the medical device industry would find it very useful and relevant. Peter LoekkeConsultant/founderSerini