The regulatory framework for cybersecurity (IT security) of medical devices is specified in the „General Safety and Performance Requirements“ section of the EU MDR and IVDR regulations. Standards and guidelines specify the requirements for implementation.
In this basic course, you will get an overview of the regulatory relevant standards and documents as well as field-tested tips, methods, tools and useful resources for the implementation of medical device cybersecurity requirements.
This basic course is also suitable for participants with no or little previous knowledge. For newcomer and start-ups, this course offers an optimal introduction to the topic of cybersecurity for medical device software.
THE SEMINAR CONTENTS
- Meaning of key terms from the fields:
- Information Security
- IT Security and
- Operational Security
- Cybersecurity requirements for medical devices from
- applicable standards
- laws and
- guidance documents
- Tips, methods, tools and other useful resources for the implementation of the requirements
- Early bird (until 4 weeks before seminar): Euro 490,- (excl. VAT)
- Standard (starting 4 weeks before the seminar): Euro 540,- (excl. VAT)
- All seminar discounts at a glance
- incl. seminar documents as PDF and a certificate of participation.
Nilaykumar Patel Msc, Chief Quality Officer, contextflow GmbH & Co-Auditor at en.co.tec
You only need a laptop with camera and microphone for our ONLINE seminars. Our eLearning platform works on all operating systems in the web browser. You will receive the seminar documents and the link to the virtual seminar room by email in due time. The seminar will be interactive – similar to a face-to-face seminar: i.e. you can ask your questions to the lecturer, there will be exercise examples and also the possibility to exchange ideas with the other participants.