Medical Devices
Medical devices are essential to modern healthcare, contributing to improved diagnostics, treatment, and quality of life. Their development spans from design and manufacturing to CE marking and clinical trials to ensure safety and efficacy. Läkemedelsakademin annually offers a wide range of trainings in medical devices, available both as on-site and online courses.
Introductory courses
Medical Devices - Introduction
The course provides an overview of the regulations governing medical devices and how to apply them in practice. You’ll gain insight into the requirements for both manufacturers and products to enable marketing within Europe.
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Clinical Trials of Medical Devices and GCP
A course providing insight into clinical trials of medical devices. It covers the basics of GCP (ISO 14155:2020), other regulations, practical advice on the application processes, and expectations during an inspection.
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E-courses on Medical Devices
Medical Devices Road to Market
This e-course provides a solid introduction to the key steps involved in bringing a medical device to market. It covers the essentials of the development process, incorporating interactive elements and knowledge checks to enhance your learning experience.
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Combination Products for Pharma - Device Perspective
This e-course offers an overview of the regulatory requirements for drug-device combination products, focusing on the device aspects under the EU Medical Device Regulation (MDR). It’s specifically tailored for individuals with a pharmaceutical background.
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Combination Products for Pharma - Device Perspective (On-Site Session with E-course)
This course is aimed at those with regulatory experience in pharmaceuticals who wish to deepen their knowledge of the medical device aspects of combination products (drug-device). It consists of an e-course and an on-site session, providing key insights into the EU regulations for combination products.
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GCP for Investigators
An e-course on Good Clinical Practice (GCP) covering the basics of the investigator’s responsibilities in clinical drug trials. Intended for investigators and delegated staff at trial sites. Meets TransCelerate’s minimum criteria for ICH E6 GCP training.
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Usability Engineering in Medical Devices
Learn the essential requirements for ensuring that medical devices meet usability standards in Europe and the United States. This course provides insights on how to practically apply the regulations to ensure compliance and successfully launch your product on the market.
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Design and Statistical Analysis of Clinical Trials
A course on study design, statistical analysis, and result interpretation for clinical trials involving drugs and medical devices. The course covers key terminology, protocol development, trial implementation, and reporting, all from an applied statistical perspective.
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Upcoming Course Dates
Combination Products for Pharma - Device Perspective, e-kurs
Combination Products for Pharma – Device Perspective (On-Site Session with E-course), dec 2024
2nd Nordic Conference on Computational Chemistry, March 2025
Usability Engineering in Medical Devices, april 2025
Regulatory documentation, content and format guide, May 2025
Boost Your Career or Make an Impact
If you work in pharmaceuticals or with medical devices, Apotekarsocieteten is your association.
Apotekarsocieteten provides a network and platform for sharing knowledge, while also giving you the opportunity to make a broader impact.
What is Medical Technology?
Medical devices are central to modern healthcare, playing a crucial role in diagnosis, treatment, and improving the quality of life for patients. These products range from simple aids like bandages to advanced technology such as MRI machines, pacemakers, and surgical robots. The development of medical technology is a complex process encompassing everything from design and manufacturing to meeting essential regulatory requirements.
For a medical device to be used within the EU, it must meet the standards for CE marking. This means the product has undergone extensive testing, and in some cases, clinical trials to ensure its safety and effectiveness. Regulations and standards for medical devices are becoming increasingly comprehensive, making in-depth knowledge of regulatory affairs and standards essential for professionals in the field.
Läkemedelsakademin offers a variety of courses and training programs in medical technology, covering everything from regulations and standards to clinical trials and product development. Our courses are available as both on-site and online options, allowing you to tailor your training to your needs.