Delivery mode
Self-paced online, Instructor-led online
The training must be completed by June 30, 2027.
Location
live online
Language
English
Health Technology Legislation and Standards
A program for professionals working with medical device regulation in the health technology sector who want to strengthen their expertise in the MDR framework, documentation requirements, and post-market obligations.
The regulatory environment for medical devices is complex, tightly controlled, and constantly evolving. Ensuring compliance requires a solid understanding of the obligations set out in the MDR 2017/745 regulation, risk classification, and technical documentation, as well as the ability to integrate these into an organization's quality management throughout the device lifecycle. This program provides an up-to-date, practice-oriented overview of how organizations can ensure device compliance and manage regulatory obligations from design through post-market surveillance.
The program brings together regulatory frameworks, documentation requirements for device and software development, and post-market obligations into a practical whole. Participants will gain the skills to apply MDR requirements from risk classification to technical documentation, carry out risk management and clinical evaluation, and build post-market processes into their organization's quality management system.
The course consists of online lectures that are recorded for later viewing, keynote presentations, practical exercises, and project work. Studies can be completed flexibly alongside work. The course is free of charge for participants.
This program is in English only. Participants must live in Finland.
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The training has been funded by the Service Centre for Continuous Learning and Employment (SECLE). The Service Centre promotes the competence development of working-age people and the availability of skilled labour. The operations of the Service Centre are overseen by the Ministry of Education and Culture and the Ministry of Economic Affairs and Employment.
Content and Schedule
The program consists of 6 lectures, which you can attend live online or watch as recordings afterwards. In addition to the lectures, the program includes practical exercises and a project assignment. The program is designed to be completed alongside work and is delivered entirely online. The content and schedule of the lectures will be published soon.
Content
Lectures and keynote speeches 
Practical exercises 
Project assignment
Certificate
Upon completing the program, you will receive a certificate demonstrating your up-to-date expertise.
For
The program is aimed at professionals working in the health technology sector, as well as individuals involved in procurement and implementation within social and healthcare organizations.
Applicants eligible for admission include individuals who belong to the above target groups, have a learning need related to the program content, and possess sufficient prerequisites for acquiring the competencies the training aims to develop.
Learning Outcomes
After completing the program, participants will be able to:
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Understand the overall regulatory framework for medical devices from the perspective of the MDR 2017/745 regulation, and apply definitions, intended use, and risk classification when assessing manufacturer obligations and market placement
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Identify the roles of national authorities, notified bodies, and harmonized standards, and apply these in demonstrating compliance and preparing documentation
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Produce and evaluate key documentation related to device and software development, including technical documentation, risk management, and clinical evaluation, and understand their role in ensuring device safety and performance
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Identify and implement post-market obligations, such as PMS systems, post-market clinical follow-up, incident reporting, and user information requirements, and integrate these into the organization's quality management system
Instructors
Craig Carlson
Craig Carlson is a University Lecturer at Aalto University’s Department of Electrical Engineering and Automation, where he began his role in early 2024. His position is unique, combining academic expertise with a strong focus on lifewide learning development, supported by Aalto’s seed funding initiative to create innovative learning opportunities for professionals.
Originally from Johannesburg, South Africa, Carlson holds a Master’s and PhD in Electrical Engineering, complemented by industry experience prior to his doctoral studies. His research journey took an unconventional turn when he explored the intersection of ultrasound technology and tattoo inks, investigating how tattoos affect medical ultrasound imaging and vice versa. This reflects his broader interest in expanding the applications of ultrasound beyond traditional diagnostics.
Currently, Carlson's work centers on identifying and shaping learning content that bridges academic knowledge with industry needs, ensuring that upskilling opportunities are relevant for professionals outside traditional degree programs. He collaborates closely with faculty and industry partners to design courses that meet evolving workplace demands.
Carlson brings a practical, interdisciplinary perspective to teaching, blending technical expertise in medical technologies with a passion for lifelong learning and innovation.
Program Fee and Registration
Fee
The training is funded by the Centre for Continuous Learning and Employment and is free of charge.
Eligibility to participate must be approved by SECLE before the training starts. Study rights begin once the funder has approved eligibility, at which point the student receives an invitation to the learning platform.
Registration
The training must be completed in full by June 30, 2027.
This program has adopted Aalto EE's new Customer ID, and it is delivered on Aalto Learning Experience Alex e-learning environment. Before ordering, please visit aaltoee.fi/customerid.
Program start