Webinar

Medical Device Software and Artificial Intelligence – The BSI perspective

Medical Device Software and Artificial Intelligence – The BSI perspective

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Medical device Software and AI
Medical device Software and AI
Red Overlay

Medical Device Software and Artificial Intelligence – The BSI perspective

Tuesday 14 November 2023
 
BSI will guide medical device manufacturers through some of the challenges around Medical Device Software (MDSW) compliance with MDR and UKCA. The attendees will have the opportunity to learn more about how BSI evaluates SAMD. There will be a focus on key requirements, guidance documents and standards. We will share the lessons learned from the past MDSW assessments under MDR and common gaps identified. The webinar will also give a unique point of view about the recent regulatory developments for Artificial Intelligence (AI), about the AI Act journey in Europe and how BSI can support the manufacturers with medical device incorporating AI.
 
The Webinar will be presented in English!
 
Agenda:
 
08:50 | Link open for participants
 
09:00 | Welcome, agenda and Speakers Intro - Flavien Del Sole, Senior BDM, BSI Regulatory Service (Medical Devices)
 
09:05 | Medical Device Software under MDR and UKCA Assessment of Medical Device Software under MDR and UKCA. How is the Notified Body evaluating software? Key requirements relating to software medical devices, key guidance documents and standards. Lessons learned on the software medical devices assessed under MDR. Speaker: Lena Gourmelon, Technical Team Manager - Active MD Regulatory Services, BSI
 
10:30 | Short break
 
10:45 | Artificial Intelligence in Medical Device: AI Act journey and how BSI can support Medical Device Manufacturers Speaker: Daniela Seneca, Regulatory Lead Artificial Intelligence, BSI Regulatory Services (Artificial Intelligence)
 
11:30 | Q&A Moderator: Flavien Del Sole, Senior BDM, BSI Regulatory Service (Medical Devices)
 
11:50 | Closing Moderator: Flavien Del Sole, Senior BDM, BSI Regulatory Service (Medical Devices)
 
Access to the presentation

Our speaker

Daniela Seneca, Regulatory Lead, Artificial Intelligence

Daniela Seneca, Regulatory Lead, Artificial Intelligence

Daniela joined BSI in 2017 as Technical Specialist, Scheme Manager and Clinical Team Lead in the Active Medical Devices Team and is currently Regulatory Lead Artificial Intelligence (AI), responsible for AI regulatory strategy, policies, procedures and accreditation/designation as a Conformity Assessment Body and Notified Body. Her main role is to establish and maintain compliance to regulatory requirements in terms of organizational, quality management processes and resources, supporting Operations in the certification activities and training program.

Daniela holds Bachelors and Masters in Biomedical Engineering, a Masters in Health Technology Assessment and has over 17 years’ experience in medical devices, including AI software, having worked in technology development, technology transfer, patents, testing, clinical studies and as medical device lead auditor/national expert for the Italian Ministry of Health in the European Commission working groups and Joint Assessments. She is a former IEEE member actively participating to the CEN-CENELEC Joint Technical Committee 21 on Artificial Intelligence.

Lena Gourmelon

Lena Gourmelon - Technical Team Manager, Active Medical Devices

Lena Gourmelon holds a Msc in Electrical Engineering and has more than 17 years’ experience in Medical Devices.

She worked in Research and development for non-invasive patient monitoring solutions including software development.

Afterwards, she joined a Quality and Regulatory department for interventional X-ray medical imaging devices and related standalone software applications.

She is a Technical Specialist and Scheme Manager within BSI Active Devices Team since 2014, specialised in the assessment Medical Device Software.