Medical Devices in the Age of AI and Cybersecurity: Regulatory Insights
Webinar Overview
As Artificial Intelligence (AI), data analytics, and connected technologies reshape healthcare, medical device regulation is undergoing a profound transformation. This webinar explores how emerging frameworks – including the EU MDR/IVDR, AI Act, GDPR, NIS2 Directive, and the European Health Data Space (EHDS) – are converging to define a new era of compliance, transparency, and digital trust in MedTech.
Led by a legal and compliance expert, this session will unpack the regulatory, ethical, and operational challenges faced by manufacturers, developers, and healthcare organizations. Participants will gain practical insights into how to embed compliance-by-design, manage cybersecurity risks, and navigate the intersection of data protection and AI governance to stay ahead in a rapidly evolving regulatory landscape.
Key Takeaways:
- Understand the regulatory integration of MDR/IVDR, AI Act, GDPR, and NIS2.
- Learn how to classify and assess AI-driven medical devices under EU and U.S. frameworks.
- Explore cybersecurity-by-design principles and obligations for MedTech.
- Discover best practices in data governance, documentation, and transparency.
- Gain insights into upcoming trends, including ethical AI and enhanced cybersecurity oversight.
Webinar Agenda
We’ll cover:
- Opening Remarks and Context
- The digital transformation of healthcare and regulatory convergence
- Why compliance is now a strategic enabler for MedTech innovation
- AI in Medical Devices: Legal and Regulatory Foundations
- What qualifies as Software as a Medical Device (SaMD)
- AI risk classification under the EU AI Act and IMDRF model
- FDA vs. EU approaches to AI-driven devices
- Cybersecurity-by-Design in MedTech
- Embedding security across the product lifecycle
- NIS2 Directive and Cyber Resilience Act obligations
- Vulnerability management and incident reporting
- Data Protection and Governance
- GDPR principles: lawfulness, minimization, accountability
- Handling sensitive health data and vendor compliance
- Cross-border data transfers and alignment with EHDS
- Practical Compliance Strategies
- Building cross-functional compliance frameworks
- Integrating AI governance, cybersecurity, and data protection
- Continuous monitoring and proactive compliance
- Future Trends & Regulatory Outlook
- AI Act enforcement timeline and ethical AI requirements
- Rising cybersecurity oversight and audits
- The future role of data protection and transparency in innovation
- Q&A and Closing Discussion
- Addressing participant questions
- Key takeaways for compliance professionals and MedTech stakeholders
Date
This webinar will take place on Wednesday, 19th November, 2025 at 08:00 PDT, 11:00 EDT, 17:00 CET.
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Presenters
Fernanda Paro, Senior Regulatory Compliance Specialist, Compliance & Risks
Fernanda is a Senior Regulatory Compliance Specialist with the Global Regulatory Compliance team, based in Barcelona. She monitors regulatory updates across North, Central, and South America, with deep expertise in Medical Device legislation.
As the project lead for a global initiative spanning multiple jurisdictions, Fernanda regularly delivers in-depth analysis on complex legal and compliance queries related to medical devices.
She holds an European Healthcare Compliance Certificate Program (EU HCCP), a postgraduate degree in Constitutional Law and a Master’s in International Trade Law, specializing in MedTech compliance with a regulatory focus on Cybersecurity and Data Protection. A qualified lawyer in both Brazil and Portugal, Fernanda is fluent in Portuguese, English, and Spanish, currently learning French, and proficient in Italian.
Patricia Weathers, Regulatory Compliance Specialist, Compliance & Risks
Patricia joined Compliance & Risks as a Regulatory Compliance Specialist in 2024. She is a certified Lead Auditor for ISO 13485 and ISO 9001, and has spent over ten years working in Quality Compliance/Assurance in the medical device and automotive manufacturing sectors.
Additionally, her background includes research and information services at the academic level and in training development.
Kahyeon Seo, Regulatory Compliance Analyst, Compliance & Risks
AKahyeon is a Regulatory Compliance Analyst at Compliance and Risks, having joined the company in 2024. She has academic backgrounds in Neuroscience and Criminology. Prior to joining Compliance & Risks, Kahyeon worked in the raw material regulatory field, focusing on chemical compliance with regulations such as RoHS, REACH, TSCA, and toxicology standards, including MSDS.
She currently monitors regulatory updates in South Korea, Greece, and U.S. states, and serves as a secondary subject matter expert for medical devices.
Orlaith Morris, Content Marketing Manager, Compliance & Risks
Orlaith is Content Marketing Manager at Compliance & Risks, working with the company since 2022 and based in Dublin. In her role, Orlaith leverages her expertise to elevate the company’s brand presence and thought leadership, delivering impactful content that resonates with the industry. With a keen focus on the ever-evolving product compliance & ESG landscapes, her work supports Compliance & Risks’ mission to help organizations stay compliant and achieve their business goals.
Prior to joining Compliance & Risks, Orlaith has years of content marketing experience working in various global industries and organizations.
