Description
Information Security, Cybersecurity & Data Protection – Achieve Compliance Successfully!
Artificial intelligence (AI) has transformed the landscape of medical devices and in vitro diagnostics (IVD), ushering in new opportunities and challenges for healthcare innovation. As these technologies become increasingly integrated into critical healthcare infrastructure, it is essential for professionals to understand the evolving regulatory and cybersecurity landscape.
Not every manufacturer is necessarily considered the provider of a high-risk AI system. Many medical device manufacturers use large language models (LLMs) from different vendors for their software development. As a result, companies assume various roles and responsibilities under the Medical Device Regulation (MDR) and the AI Act.
This introductory course provides a comprehensive overview of the fundamental requirements for AI-based medical devices and IVDs, with a focus on compliance with the NIS2 Directive and ISO 27001 standards.
In this seminar, our expert expertly illustrates the interconnections between MDR, the AI Act, and the NIS2 directive. Using best practice examples – especially from ISO/IEC 27001 certification – he demonstrates actionable solutions. Data protection, as an essential aspect, is also thoroughly addressed.
SEMINAR CONTENT
NIS2 Requirements and ISO 27001 for AI-based Medical Devices and IVD
- Requirements for information security, cybersecurity and privacy protection
- Implementation of information security management systems
- NIS 2 Directive – cybersecurity risk-management and reporting obligations
- Implementing a compliance strategy within the fields of medical devices, information security, artificial intelligence and data protection
Date
27.11.2025, 13:30 – 17:30
PARTICIPANTS
Regulatory Affairs Manager, Quality Management Specialist / QMS Manager, Legal Compliance Officer, Product Manager – Medical Devices / IVD, R&D Manager – AI-Based Medical Technologies, Post-Market Surveillance (PMS) Specialist, Clinical & Regulatory Strategist, Risk Management Specialist, Software as a Medical Device (SaMD) Expert, Internal or External Auditor – MDR, IVDR, ISO 13485, IT & Security Managers and Data Protection Officers
This basic course is part of our online course: DEVELOPING AI-BASED MEDICAL DEVICES AND IVD IN COMPLIANCE WITH REGULATIONS.
YOUR TRAINER
- Dr. MMag. Markus Speiser: As a doctor of law, trained business economist, project manager, and data protection officer, I support economic actors in this very exciting environment so that they can bring medical devices to market. https://www.linkedin.com/in/markus-speiser-b362b11ba/
COSTS
- Early bird (until 4 weeks before the seminar): Euro 260,- (excl. VAT)
- Standard (starting 4 before the seminar): Euro 305,- (excl. VAT)
- incl. seminar documentation as PDF and certificate of participation
- All seminar discounts at a glance
EVENT LOCATION: ONLINE
You will receive the course documents and a link to the virtual seminar room via email in a timely manner. Each module is designed to be interactive, similar to a face-to-face seminar. You can ask the lecturer questions, complete exercises, and exchange ideas with the other participants.
