--- title: "SaMD, IEC 62304 and IEC 82304-1 – Practitioner Training" description: "This online course with live virtual classroom sessions focuses on SaMD aspects according to the IEC 62304 and IEC 82304-1 standards." featured_image: "https://medicaldevicehq.com/wp-content/uploads/2024/02/SaMD2B-Samd-iec-62304-and-iec-82304-1​​-practitioner-training.jpg" url: "https://medicaldevicehq.com/samd-practitioner-level-blended-course/" date_modified: "2026-09-25T15:31:55+02:00" --- [Pricing](#courseplan-samd2b) [Modules](#coursemodules-samd2b) [Overview](#courseoverview-samd2b) [Benefits](#benefitsforyou-samd2b) [Instructor](#courseins-samd2b) [FAQ](#info-samd2b) [Reviews](#reviews-samd2b) --- # SAMD, IEC 62304 AND IEC 82304-1 – Practitioner Training - Blended course: online course + 2 live virtual classroom sessions - EU and US requirements - Beginner - advanced - Last updated - Aug 2026 --- [Pricing plan](#courseplan-samd2b) [Overview](#courseoverview-samd2b) [Modules](#coursemodules-samd2b) [Benefits](#benefitsforyou-samd2b) [Instructor](#courseins-samd2b) [Reviews](#reviews-samd2b) --- ### Learn how to develop and maintain Software as a Medical Device (SaMD) with knowledge and confidence.  The course looks at the development aspects of the IEC 62304 standard. It also includes an introduction to the IEC 82304-1 standard and its relation to ISO 13485 (quality management). In the course, you will also learn about the relationship to ISO 14971 (risk management) when developing medical device software. You learn the theory first during the [online course](https://medicaldevicehq.com/introduction-to-samd-iec62304-and-iec-82304-1-online-course/), and then apply that theory during the two live virtual classroom sessions. ![Free online short course on Software for medical devices and IEC 62304](https://fast.wistia.com/embed/medias/cajl1bmpv7/swatch) ## Online course + 2 Live classroom sessions + Templates € 1149/ seat [Cancellation policy](https://medicaldevicehq.com/classroom-session-cancellation-policy/) [](/accredited-cpd-training-provider/) | | | | --- | --- | | Course length | approx. 17-36 hours (28 CPD points) | | Next classroom sessions | 8-9 Dec, 2026 1PM-4:30PM CET | [Register for the blended course](#elementor-action%3Aaction%3Dpopup%3Aopen%26settings%3DeyJpZCI6IjM0MDA1NiIsInRvZ2dsZSI6ZmFsc2V9) [Register for classroom sessions only](/store/courses/classroom/store/courses/classroom-sessions/samd-iec-62304-and-iec-82304-1-classroom-sessions/) --- ## Select your course plan --- QUICKSTART ** ** **FREE ** ![Checkmark MDHQ](https://medicaldevicehq.com/wp-content/uploads/2022/07/checkmark-circle-mdhq.svg)  Average completion time  **1-3 hours** ![Checkmark MDHQ](https://medicaldevicehq.com/wp-content/uploads/2022/07/checkmark-circle-mdhq.svg)  Total video duration** 32 minutes** ![Checkmark MDHQ](https://medicaldevicehq.com/wp-content/uploads/2022/07/checkmark-circle-mdhq.svg)  Number of quizzes **5** ![Checkmark MDHQ](https://medicaldevicehq.com/wp-content/uploads/2022/07/checkmark-circle-mdhq.svg)  30 days access to the course ![Checkmark MDHQ](https://medicaldevicehq.com/wp-content/uploads/2022/07/checkmark-circle-mdhq.svg)  Digital course companion [ Register ](https://medicaldevicehq.com/quickstart-to-software-for-medical-devices-iec-62304/) ONLINE ** ** **€ 499** ![Checkmark MDHQ](https://medicaldevicehq.com/wp-content/uploads/2022/07/checkmark-circle-mdhq.svg)  Average completion time  **10-29 ****hours** ![Checkmark MDHQ](https://medicaldevicehq.com/wp-content/uploads/2022/07/checkmark-circle-mdhq.svg)  Total video duration **7.5 hours** ![Checkmark MDHQ](https://medicaldevicehq.com/wp-content/uploads/2022/07/checkmark-circle-mdhq.svg)  CPD points **21 ** ![Checkmark MDHQ](https://medicaldevicehq.com/wp-content/uploads/2022/07/checkmark-circle-mdhq.svg)  Number of quizzes **37** ![Checkmark MDHQ](https://medicaldevicehq.com/wp-content/uploads/2022/07/checkmark-circle-mdhq.svg)  Final exam ![Checkmark MDHQ](https://medicaldevicehq.com/wp-content/uploads/2022/07/checkmark-circle-mdhq.svg)  Course certificate ![Checkmark MDHQ](https://medicaldevicehq.com/wp-content/uploads/2022/07/checkmark-circle-mdhq.svg)  Ask the instructor ![Checkmark MDHQ](https://medicaldevicehq.com/wp-content/uploads/2022/07/checkmark-circle-mdhq.svg) 6 months access to the course and instructor ![Checkmark MDHQ](https://medicaldevicehq.com/wp-content/uploads/2022/07/checkmark-circle-mdhq.svg)  Digital course companion [ Buy now ](/introduction-to-samd-iec62304-and-iec-82304-1-online-course/) ONLINE LIFETIME ** ** **€ 599** ![Checkmark MDHQ](https://medicaldevicehq.com/wp-content/uploads/2022/07/checkmark-circle-mdhq.svg)  Average completion time  **10-29 hours** ![Checkmark MDHQ](https://medicaldevicehq.com/wp-content/uploads/2022/07/checkmark-circle-mdhq.svg)  Total video duration **7.5 hours** ![Checkmark MDHQ](https://medicaldevicehq.com/wp-content/uploads/2022/07/checkmark-circle-mdhq.svg)  CPD points **21 ** ![Checkmark MDHQ](https://medicaldevicehq.com/wp-content/uploads/2022/07/checkmark-circle-mdhq.svg)  Number of quizzes **37** ![Checkmark MDHQ](https://medicaldevicehq.com/wp-content/uploads/2022/07/checkmark-circle-mdhq.svg)  Final exam ![Checkmark MDHQ](https://medicaldevicehq.com/wp-content/uploads/2022/07/checkmark-circle-mdhq.svg)  Course certificate ![Checkmark MDHQ](https://medicaldevicehq.com/wp-content/uploads/2022/07/checkmark-circle-mdhq.svg) Ask the instructor ![Checkmark MDHQ](https://medicaldevicehq.com/wp-content/uploads/2022/07/checkmark-circle-mdhq.svg) Lifetime access to the course and instructor ![Checkmark MDHQ](https://medicaldevicehq.com/wp-content/uploads/2022/07/checkmark-circle-mdhq.svg)  Digital course companion [ Learn more ](/introduction-to-samd-iec62304-and-iec-82304-1-online-course/) BLENDED ** ** **YOU ARE HERE** **€ 1149** ![Checkmark MDHQ](https://medicaldevicehq.com/wp-content/uploads/2022/07/checkmark-circle-mdhq.svg)  Average completion time  **17-36 hours** ![Checkmark MDHQ](https://medicaldevicehq.com/wp-content/uploads/2022/07/checkmark-circle-mdhq.svg)  Total video duration **7.5 hours** ![Checkmark MDHQ](https://medicaldevicehq.com/wp-content/uploads/2022/07/checkmark-circle-mdhq.svg)  CPD points **28 ** ![Checkmark MDHQ](https://medicaldevicehq.com/wp-content/uploads/2022/07/checkmark-circle-mdhq.svg)  Number of quizzes **37** ![Checkmark MDHQ](https://medicaldevicehq.com/wp-content/uploads/2022/07/checkmark-circle-mdhq.svg)  Final exam ![Checkmark MDHQ](https://medicaldevicehq.com/wp-content/uploads/2022/07/checkmark-circle-mdhq.svg)  Course certificate ![Checkmark MDHQ](https://medicaldevicehq.com/wp-content/uploads/2022/07/checkmark-circle-mdhq.svg)  Ask the instructor ![Checkmark MDHQ](https://medicaldevicehq.com/wp-content/uploads/2022/07/checkmark-circle-mdhq.svg)  Lifetime access to the course and instructor ![Checkmark MDHQ](https://medicaldevicehq.com/wp-content/uploads/2022/07/checkmark-circle-mdhq.svg)  Digital course companion ![Checkmark MDHQ](https://medicaldevicehq.com/wp-content/uploads/2022/07/checkmark-circle-mdhq.svg)  Classroom sessions (2 \* 3.5 hours) ![Checkmark MDHQ](https://medicaldevicehq.com/wp-content/uploads/2022/07/checkmark-circle-mdhq.svg)  Templates [ Register ](#samd2b2023) IN-HOUSE TRAINING ** ** **CONTACT US** Tailored training to meet your company's needs [ Get a quote ](#rmquote) Average completion time ** The average course completion time varies based on prior knowledge and individual course goals. It includes video viewing, quizzes, and final exam. Total video duration ** This is the total recorded video duration for the whole course (excludes quizzes and exam). Participants often rewatch videos for better comprehension. CPD points ** This course is CPD-accredited. You will receive a certificate awarding you CPD points following completion of the training. [Learn more ](https://medicaldevicehq.com/accredited-cpd-training-provider/) Number of quizzes ** This is the total number of quizzes in the course. They are spread throughout the course, typically at the end of each lesson. They can, for example, be multiple choices, true/false, or short written answers. Course access ** If you purchase a course plan with lifetime access to the online course, [lifetime access](/online-course-life-time-access/) is granted upon completion of the course and final exam within six months from enrollment. Access continues as long as the course remains available on the website without significant changes. Digital course companion ** The personal printed course companion serves as a comprehensive summary of the online course, condensing the key concepts into concise bullet points accompanied by relevant images and helpful flowcharts. Final exam ** The final exam consists of 30-45 randomly selected quiz questions, taken once under timed conditions, for verification of training and course certificate issuance. No pass/fail, but the score is recorded in training record. Course certificate ** Upon completion of the final exam, two course certificates are issued: 1) A social media-friendly certificate that can be easily shared on LinkedIn. 2) A PDF course certificate, including the final exam score, suitable for your training records. When attending the blended course, a course certificate covering both the online course and the classroom session is also issued. Ask the instructor ** Enrolled learners can utilize the comment fields in each lesson to ask questions, which are answered by the course creator. Please note that the course creator provides responses to questions of a generic nature and they do not substitute regular consulting assignments. Classroom sessions (2 \* 3.5 h) ** The classroom sessions, held over two half-days (3.5 hours each), provide a highly interactive environment for applying the theory learned during the online course. Guided by an expert instructor, there are real-life case scenarios to work through and plenty of time for discussions and questions. It's an opportunity to further enhance understanding and practical skills in a collaborative setting. Templates ** Our exclusive collection of time-saving templates are designed to enhance the online course experience. These templates provide practical knowledge and assist in implementing corresponding requirements to improve operations. ## [QUICKSTART](https://medicaldevicehq.com/quickstart-to-software-for-medical-devices-iec-62304/) ## FREE 1-2 hours 32 minutes / 5 30 days access [Register](https://medicaldevicehq.com/quickstart-to-software-for-medical-devices-iec-62304/) ## [ONLINE](/introduction-to-samd-iec62304-and-iec-82304-1-online-course/) ## € 499 10-29 hours 7.5 hours 21 CPD points 37 6 months access [Buy now](/introduction-to-samd-iec62304-and-iec-82304-1-online-course/) ## You're here ## [ONLINE LIFETIME](/introduction-to-samd-iec62304-and-iec-82304-1-online-course/) ## € 599 10-29 hours 7.5 hours 21 CPD points 37 Lifetime access [Buy now](/introduction-to-samd-iec62304-and-iec-82304-1-online-course/) ## [BLENDED](#elementor-action%3Aaction%3Dpopup%3Aopen%26settings%3DeyJpZCI6IjM0NDk3OSIsInRvZ2dsZSI6ZmFsc2V9) ## € 1149 17-36 hours 7.5 hours 28 CPD points 37 Lifetime access [Register](#elementor-action%3Aaction%3Dpopup%3Aopen%26settings%3DeyJpZCI6IjM0NDk3OSIsInRvZ2dsZSI6ZmFsc2V9) ## [IN-HOUSE TRAINING](#elementor-action%3Aaction%3Dpopup%3Aopen%26settings%3DeyJpZCI6IjM0MjAxNyIsInRvZ2dsZSI6ZmFsc2V9) ## Contact us Tailored training to meet your company’s needs [Get a quote](#elementor-action%3Aaction%3Dpopup%3Aopen%26settings%3DeyJpZCI6IjM0MjAxNyIsInRvZ2dsZSI6ZmFsc2V9) --- ## Course overview --- This course consists of two parts: 1. SaMD, IEC 62304 and IE C82304-1 online course 2. Two half-day live virtual classroom sessions held by the course creator First, you complete the popular [SaMD, IEC 62304 and IEC 82304-1 online course](https://medicaldevicehq.com/introduction-to-samd-iec62304-and-iec-82304-1-online-course/). It covers topics such as how to efficiently plan and document software, getting requirements right, how to approach software architecture and software risk management, and how to perform software safety classification. SaMD specific topics include software types and terminology, product requirements in IEC 82304-1, how to manage cybersecurity and artificial intelligence. You can start the online course immediately and you must successfully complete the final exam prior to the classroom sessions. **If you have already completed the online course, you can register for the [classroom sessions only](https://medicaldevicehq.com/store/courses/classroom/store/courses/classroom-sessions/samd-iec-62304-and-iec-82304-1-classroom-sessions/).** The unique, highly interactive live virtual classroom sessions are facilitated by [Christian Kaestner](https://www.linkedin.com/in/christiankaestner/), an expert in this field. During the sessions, you get to apply the theory you have learnt via case studies, workshops, and discussions. There is plenty of time for Q&As, and with a maximum of 8 people per classroom session, all participants have the opportunity to learn first-hand from an industry expert. A digital course companion is included, as well as time-saving templates on how to implement software for medical devices effectively and efficiently. We recommend this course to those working with SaMD development, such as R&D engineers, quality assurance department and auditors of SaMD. Please note, the course does not cover actual coding. --- - This course is CPD-accredited. You will receive a certificate awarding you CPD points following completion of the training. - Christian Kaestner is a member of the Swedish standardisation committee TC 62/SC 62A and is actively involved in authoring the updated IEC 62304 at the international level. [![CDP accreditation badge](https://medicaldevicehq.com/wp-content/uploads/2024/04/cpd-accreditation-badge.png)](/accredited-cpd-training-provider/) ![SIS Standard Developer 2025](https://medicaldevicehq.com/wp-content/uploads/2025/03/standardeveloper2025en.png) --- ## What is a blended course? --- ![Free explanatory video on blended courses offered by Medical Device HQ](https://fast.wistia.com/embed/medias/t3w3e9h0ux/swatch) Our blended learning courses combine the best of both worlds: online training and two half-day live virtual classroom sessions afterwards. The online training allows for the flexibility in the way you learn, so that you can learn in a way which suits you best. You can access it whenever and wherever you want, and you can stop, start, and repeat the lessons and quizzes as often as you would like. To help maximise your learning, you can check your knowledge and understanding every step of the way by taking the assessment test beforehand, as well as the checkpoint quizzes that are found throughout the course. Ultimately, you will take a final exam at the end of the course. The classroom sessions are highly interactive and focuses on applying the theory you have learnt during the online course with the guidance of the expert instructor. There are real life case scenarios to work through and plenty of time for discussions and questions. [Register for the blended course](#elementor-action%3Aaction%3Dpopup%3Aopen%26settings%3DeyJpZCI6IjM0MDA1NiIsInRvZ2dsZSI6ZmFsc2V9) [Register for classroom sessions only](/store/courses/classroom/store/courses/classroom-sessions/samd-iec-62304-and-iec-82304-1-classroom-sessions/) --- ![Christian Kaestner portrait](https://medicaldevicehq.com/wp-content/uploads/2021/05/Christian-Kaestner-portrait.jpg) Christian Kaestner is a consultant and entrepreneur with a wealth of knowledge about the medical device industry. He is an expert member of the project team authoring IEC 62304 and also actively participated in the creation of IEC 82304-1. He is currently involved in the authoring of the updated IEC 62304 as part of TC 62/SC 62A, and serves as convener of TC 62/ahG9, a group tasked with finding consensus regarding the understanding of AI-related terms and concepts (e.g., ISO/IEC 22989-2) in IEC TC 62. He has extensive experience of medical device development and, as a software developer, a strong dedication to software development. In the software domain he has worked in many roles such as software developer, project manager, auditing and quality management. --- ## Benefits for you --- #### ![Checkmark MDHQ](https://medicaldevicehq.com/wp-content/uploads/2022/07/checkmark-circle-mdhq.svg) Understand why and how to work with software development Software development for medical devices can be made incredibly abstract if there is too much focus on the intangible requirements instead of how to actually do the work.  This course is very practical, you will be working on realistic tasks relating to the software lifecycle according to IEC 62304 and the product standard IEC 82304-1. #### ![Checkmark MDHQ](https://medicaldevicehq.com/wp-content/uploads/2022/07/checkmark-circle-mdhq.svg) Direct access to standards authors Gain exclusive up to the minute information by learning from authors of the standards. Our courses are developed by members of the standardization committees involved at both national and international levels, ensuring you receive first-hand knowledge and insights.  #### ![Checkmark MDHQ](https://medicaldevicehq.com/wp-content/uploads/2022/07/checkmark-circle-mdhq.svg) Interactive instructor engagement Our instructors are passionate about what they do, bringing their expertise and love for the subject into the learning experience. Participate in active learning by asking questions directly to the instructor, taking part in group workshops and discussions. This allows you to seek clarification, share insights, apply and transfer knowledge. ## Course structure --- ![Blended learning journey](https://medicaldevicehq.com/wp-content/uploads/2025/04/Blended-learning-journey-2025-v4-min-1.jpg) ## Online course --- The online course comprises a mixture of pre-recorded videos, quizzes, and a final exam. It is self-paced and flexible so that you can start, stop, and repeat as much as you like. You will have [lifetime access](https://medicaldevicehq.com/online-course-life-time-access) to the online course (conditions apply).  The [SaMD, IEC 62304 and IEC 82304-1 online course](https://medicaldevicehq.com/introduction-to-samd-iec62304-and-iec-82304-1-online-course/) consists of 13 lessons which are outlined below. ### Lesson 1. Introduction - Welcome - What you need to know - Set you course completion date - Pre-course asssessment quiz ### Lesson 2. Introduction to software and medical devices - What is software and what makes it different? - Software types and terminology - Introduction to the regulatory landscape - Introduction to classification of medical devices and software - Introduction to risk ### Lesson 3. Introduction to SaMD standards and IEC 82304-1 - SaMD relevant standards - The relationship between IEC 82304-1 and ISO 13485 - Product requirement in IEC 82304-1 ### Lesson 4. Introduction to IEC 62304 - Scope and general terminology – Part - Scope and general terminology – Part 2 - General requirements (IEC 62304) - Development process and compliance - Software safety classification – Part 1 - Software safety classification – Part 2 - Software safety classification – Part 3 ### Lesson 5. Software and risk management - Understanding software risk management - Cybersecurity - Development process as risk control – Part 1 - Development process as risk control – Part 2 - Software risk management in IEC 62304 – Part 1 - Software risk management in IEC 62304 – Part 2 - Software causes - Software risk control measures ### Lesson 6. Software planning - Development planning – Part 1 - Development planning – Part 2 - Development planning – Part 3 - Configuration management - SOUPs – How to manage and document – Part 1 - SOUPs – How to manage and document – Part 2 ### Lesson 7. Software design - Software requirements – Part 1 - Software requirements – Part 2 - Software architecture – Part 1 - Software architecture – Part 2 - Software architecture and cloud services - Quality control of cloud services - Software detailed design - Software design – AI/ML – Part 1 - Software design – AI/ML – Part 2 - Software unit implementation ### Lesson 8. Software testing - Software integration testing - Software system testing ### Lesson 9. Software release and post release management - Software release per IEC 62304 - SaMD product release per IEC 82304-1/ ISO 13485 - Maintenance plan - Problem resolution – the process - Change control ### Lesson 10. Wrap up - Wrap up ### Lesson11. Final Exam - Final Exam ### Lesson 12. Course Evaluation - Course evaluation ### Lesson 13. Classroom session info, case study & more! - Learn more in a live virtual class - The live virtual class product - Get your questions answered on the live virtual class ## Classroom sessions --- You will attend these two half-day live virtual instructor-led classroom sessions via Zoom. The focus is on practicing the new skills, knowledge, and understanding learnt during the online course, in a relaxed environment, with the guidance of an expert instructor. There are real-life case scenarios to work through, and plenty of time for discussions and questions. The live virtual classes will cover all aspects of the IEC 62304 standard and the relationship between the IEC 62304, IEC 82304-1 and other standards such as ISO 14971. The maximum number of people in a classroom session is 8. Please note, the classroom sessions will have participants from both this course and [Software for Medical Devices and IEC 62304 – Practitioner Training](https://medicaldevicehq.com/software-for-medical-devices-practitioner-level-blended-course/) course. Included is a digital course companion and the following time-saving templates: - SOUP documentation - Software development plan - Software requirement verification - Hazard traceability matrix with software - Software safety classification [Register for the blended course](#elementor-action%3Aaction%3Dpopup%3Aopen%26settings%3DeyJpZCI6IjM0MDA1NiIsInRvZ2dsZSI6ZmFsc2V9) [Register for classroom sessions only](/store/courses/classroom/store/courses/classroom-sessions/samd-iec-62304-and-iec-82304-1-classroom-sessions/) ## Frequently asked questions --- ### Is the course a live webinar? The blended course consists of two parts: the online course, and two half-day live virtual classroom sessions. The online course is made up of carefully scripted pre-recorded videos in order to maximise your learning. The live virtual classroom sessions are virtual face-to-face sessions where you will be interacting with the instructor and the other course participants via Zoom. You are required to be visible on video when taking the classroom sessions. ### Can I view the online course on a mobile device? Yes, you can. ### How long does it take to complete the course? The time spent on the course varies greatly. If you are a beginner or have very high ambitions, you will typically spend more time on it. If you are already experienced in the field, you will probably finish it more quickly. The online course takes 10-29 hours to finish on average. You do not have to watch the whole course at once. In fact, you can pause, resume, and replay as often as you like.  The two half-day live virtual classroom sessions take approximately 7 hours in total. ### Where can I find my course certificate? You will be receiving a course certificate after completing the final exam. The course certificate is available when you log in to your account. Go to “My Courses”, and scroll down. You will find it under “Your Course Certificates”. After successfully completing the classroom session, you will receive a course certificate covering both the online course and the classroom session by email. ### Do you offer volume discounts? If you wish to buy 3 or more seats, we invite you to reach out using the contact form to discuss discount options. Please note, if there are more than 5 people from your organisation wishing to take the course, consider arranging an in-house course. The price will be lower, and the course can be customised to your needs. ### How long will I have access to the course? If you complete the final exam within 6 months of enrolment, you will have [lifetime access](https://medicaldevicehq.com/online-course-life-time-access) to the online course (conditions apply). If you do not, your course access will expire after 6 months. ### Do I get a course companion? Yes, you can download a course companion within the online course. It contains a selection of key slides from the course and is in PDF format. ### What is the maximum number of participants in the live virtual classroom? The maximum number of participants for the live virtual classroom session is 8. ### Can I fail the final exam? There is no pass/fail score on the exam as such, but you are required to achieve 85% or more on the final exam to be allowed to attend the classroom session. The check-point quiz questions that are available during the online course will be a good model of what you will get on the final exam. If you do not achieve 85%, the final exam can be reset for an administrative fee of 50 EUR, and you can take it again. ### What if I have already completed the online course and taken the final exam? If you have already completed the online course and taken the final exam more than 3 weeks prior to the classroom sessions, and regardless of whether you have achieved >85%, we will reset the final exam for you for free. You will need to retake the final exam by 3pm CET the day before the classroom sessions. This is because we insist all participants have the information fresh in their mind in order to maximise the learning experience in the live virtual classroom sessions. ### What are the pre-requisites for this course? There are no pre-requisites for this course. ### Is the instructor accredited or certified to give this training? The instructor is an expert member of the project team authoring IEC 62304 and also actively participated in the creation of IEC 82304-1. He has extensive experience of medical device development and a strong dedication to software development. In the software domain he has worked in many roles such as software developer, project manager, auditing and quality management. This ensures the instructor has access to leading-edge knowledge and information, which is the highest qualification available for teaching the course. ### What payment methods do you accept? We offer a number of payment methods including credit card, GooglePay, ApplePay, PayPal, wire transfer/invoice depending on the country you are buying from. If you cannot find your country on the list at checkout or you are not given wire transfer as a payment method, you can submit your order via our [invoice order form](https://medicaldevicehq.com/invoice-order-sign-up/). ### This course is CPD accredited. What does it mean? Medical Device HQ is proud to be an [accredited CPD provider](/accredited-cpd-training-provider/), demonstrating our commitment to your continued professional development with high-quality training courses. A CPD record showcases your professional growth, boosts confidence in your abilities, and can be presented to management for better career opportunities. As a participant of a CPD certified course, you will receive a certificate awarding you CPD points following completion of the training. ### How many CPD hours and CPD points can I claim? Upon completion of this blended course, you are awarded 28 CPD points. Your course certificate will display the exact number of CPD points. [Read more](https://medicaldevicehq.com/accredited-cpd-training-provider/). ## Reviews --- ## Testimonial Carousel Software Team Lead MagVenture An excellent course led by an experienced industry expert! Delivered with energy, it had clear, pragmatic concepts. The team learned skills that will improve performance and save time. Highly recommend! ![Ask Møller - Medical Device HQ online course review](https://medicaldevicehq.com/wp-content/uploads/2025/02/Ask-Moller-image.jpg) Senior Bioinformatics Manager Exact Sciences The Software as a Medical Device, IEC 62304 and IEC 82304-1 blended course was an excellent learning experience. The content was highly engaging, and I picked up numerous practical insights that I can apply in my daily work. I feel significantly more confident in working with these standards now, and I’m eager to start applying the new ideas. The course was incredibly useful overall, and I would highly recommend it to any colleague looking to deepen their knowledge in this area. ![Joyce Kok testimonial](https://medicaldevicehq.com/wp-content/uploads/2024/10/Joyce-Kok-Image.png) Software Engineer Self-employed The blended course on SaMD, IEC 62304, and IEC 82304-1 was highly engaging and informative. The instructor was knowledgeable, and the interactive format made learning effective. I gained practical tools I can apply immediately and now feel much more confident in SaMD regulations. Highly recommended! ![Bertrand Wateet - Medical Device HQ course review](https://medicaldevicehq.com/wp-content/uploads/2025/04/Bertrand-Wateet-scaled.jpeg) Head of Software Development Cyber Surgery The SaMD blended course was fantastic and provided a great learning experience. With a knowledgeable presenter, the contents of the course was incredibly well put together which made all concepts very clear to understand. I also feel confident in applying the concepts taught at a competent level. It has left me highly motivated to implement all the new concepts. ![Carlos Santiago - MDHQ course review](https://medicaldevicehq.com/wp-content/uploads/2024/12/Carlos-Santiago-review-portrait.jpeg) Software Engineer UNEEG medical A/S From a software developer's point of view, the course gave me an excellent and practical look into how to understand IEC 62304 and IEC 82304-1. Christian is extremely knowledgeable, both from a high-level, but he also has a background on the practicalities of actually developing SaMD. I found this extremely engaging and helpful. ![Tyler Huffman testimonial](https://medicaldevicehq.com/wp-content/uploads/2024/10/Tyler-Huffman-Image.jpeg) Regulatory Affairs (PMS) Specialist CareDx AB Attending the course was a truly great learning experience during which I learnt a lot of things I can now use in my everyday work. Christian is not only an amazingly knowledgeable presenter, but also one that knows how to make the topic very interesting and delivers it at the right pace! As regards the online part of the course, I found the quiz questions very useful. Overall, the course is a perfect mix of high-level content and details. ![anna-bereza-jarocinska-testimonial](https://medicaldevicehq.com/wp-content/uploads/2024/03/Anna-Bereza-Jarocinska-image-scaled-e1711619847306.jpeg) Manager Medical Physics and Software Development MagForce, the Nanomedicine Company What makes this training stand out from others is the fact that it can be rewatched multiple times. This allows everyone to learn at their own pace, tailoring the experience to fit individual needs. Each individual can develop their own system to maximize their understanding. ![Saka Silprasit.JPG](https://medicaldevicehq.com/wp-content/uploads/2024/10/Saka-Silprasit.JPG.jpg) Senior Quality Engineer Philips (Remote Diagnostics Technologies) I found this a very informative introductory course, providing valuable insight into ways of interpreting and working with IEC 62304. It is a very well structured course and includes real scenarios of software development, useful links, templates and examples of tools used in the industry. ![Stacey Finn portrait](https://medicaldevicehq.com/wp-content/uploads/2020/11/Stacey-Finn-image.jpg) Head of QA ConvergeHEALTH by Deloitte This is one of the most comprehensive IEC 62304 online courses available in the market. The content is excellent and covers all aspects of the standards as well as practical applications to implement the standard. I highly recommend this course to anyone looking for IEC 62304 training. ![Kamran Younis portrait](https://medicaldevicehq.com/wp-content/uploads/2020/11/Kamran-Younis-image.jpg) --- ## Register for a course --- If you are already prepared to take a course, you can register for one of our upcoming blended courses. You’ll have 24 hours to cancel your reservation in case you can’t come. [Register for a course](#elementor-action%3Aaction%3Dpopup%3Aopen%26settings%3DeyJpZCI6IjM0MDA1NiIsInRvZ2dsZSI6ZmFsc2V9) ## Still haven’t decided? 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