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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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"

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.

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

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

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Valmed A(I)cademy® is a digital learning platform providing doctors and medical professionals with specialist knowledge about AI in everyday medical practice. We offer CME accredited courses in various specialist areas for both beginners and experts. The content of the courses is designed to be product- and service-neutral. The scientific directors and the instructors disclose potential conflicts of interest to the participants. The courses may be sponsored, which is disclosed on a course-specific basis, as are the respective total expenses.

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