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Course

5. Certification of medical devices and medical software

  • CME-certified course
  • CME points: 2 x 2
  • Modules: 2
  • Learning time: 2 x 45 minutes
  • Speaker: Dr. Vera Rödel
  • On demand
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Overview
Digitalisation is increasing the relevance of software solutions in the medical field, particularly in terms of diagnosis and therapy. These technologies enable faster, more precise analysis of medical data and support complex decision-making processes. Medical software optimises workflows and increases efficiency through automation and extensive databases that enable faster disease detection and treatment. 

The use of software for diagnosis and therapy determination can significantly improve the quality of patient care. By providing evidence-based information and decision support, doctors can make better-informed decisions and ensure personalised treatment for their patients.

The course is divided into two modules: "Certification of medical devices and medical software" and "Specialisation: Certification of medical devices and medical software"

After completing this course

  • you will be able to explain why medical software is subject to strict regulatory requirements and how these affect patient care.
  • you will understand the importance of CE registration in ensuring the safety and effectiveness of software.
  • you will be able to explain how CE registration confirms that medical software fulfils essential requirements for safety, performance and reliability.
  • you will understand how compliance with these requirements increases confidence in the safety and effectiveness of the software and improves patient care.
  • you will be able to recognise the growing importance of medical software in the healthcare sector due to the need for efficient diagnostic and therapy support tools.
  • you will understand why CE registration is critical to ensure the highest quality standards for these software solutions.
  • you will be able to explain what tasks authorised persons have.
  • you will know the conformity assessment procedure.
  • you will know the three process types of the quality management system.
  • you will understand why registrations, UDI and Eudamed are crucial for the market launch.
  • you will be able to describe what post-market surveillance involves.
Course contents

Course modules

The course speaker

Dr. Vera Rödel, MMHM

Biography
Dr. Vera Rödel holds a Doctor of Laws and a Master's in Health and Medical Management. With over 12 years of experience in the pharmaceutical industry, Dr. Rödel has specialised in pharmaceutical law, antitrust and risk governance roles. Her extensive legal expertise and deep understanding of health and medical management have been instrumental in developing Valmed A(I)cademy®.

Educational background
Doctor of Laws, Johannes Gutenberg University Mainz
Master in Health and Medical Management (MHMM), FAU Erlangen-Nürnberg
Transparency

Conflicts of interest

The conflicts of interest can be viewed by clicking here.

Sponsorships

The following company is a sponsor: Merck Healthcare Germany GmbH. The expenses of Merck Healthcare Germany GmbH for one training unit amount to approximately € 5,000.
One-off costs for the technical realisation amount to approximately € 44,000. 
CME points

CME-accredited

Our courses are CME-accredited by the Medical Association of Hessen. Our courses also offer European CME points (ECMEC®s).
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