Health Technology Legislation and Standards
A program for professionals working in medical device regulation within the health technology sector who want to build their expertise in the MDR framework, documentation requirements, and post-market obligations.
The regulatory landscape for medical devices is complex, tightly controlled, and constantly changing. Ensuring compliance calls for a solid grasp of the obligations set out in the MDR 2017/745 regulation, risk classification, and technical documentation, along with the ability to embed these into an organization's quality management across the device lifecycle. This program offers an up-to-date, practice-oriented look at how organizations can ensure device compliance and manage regulatory obligations from design through post-market surveillance.
The regulatory landscape for medical devices is complex, tightly controlled, and constantly changing. Ensuring compliance calls for a solid grasp of the obligations set out in the MDR 2017/745 regulation, risk classification, and technical documentation, along with the ability to embed these into an organization's quality management across the device lifecycle. This program offers an up-to-date, practice-oriented look at how organizations can ensure device compliance and manage regulatory obligations from design through post-market surveillance.
Schedule:
Rolling intake, the training must be completed in full by June 30, 2027.
Teaching time:
Self-paced
Topic:
Health care and social services
Form of learning:
Online
Provider:
Aalto University Lifewide Learning
Level:
Intermediate
Fee:
€ 0.00
Application period:
No application needed
Target group and prerequisites
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.
Course description
The program brings regulatory frameworks, documentation requirements for device and software development, and post-market obligations together into a practical whole. Participants will gain the skills to apply MDR requirements from risk classification through technical documentation, carry out risk management and clinical evaluation, and build post-market processes into their organization's quality management system.
The program includes online lectures (recorded for later viewing), keynote presentations, practical exercises, and project work. Studies can be completed flexibly alongside work, and the program is free of charge for participants.