para a versão em português.
On 27 September,
at 2.30pm, the Laboratory for Automatics and Systems (LAS) of the Instituto Pedro Nunes (IPN) will hold an online Webinar entitled "AI act and the European Medical Devices Regulation
". Registration via this link
The main aim of this Webinar will be to provide guidance and clarification on the complex landscape of artificial intelligence (AI) and the regulation of medical devices in Europe. Topics such as the transition times and applicability of the European regulation of medical devices will be covered, as well as the proposed AI regulation focussed on the development of these devices and its impact. This is an opportunity to deepen your knowledge of the implications of these regulations and clarify any doubts.
The session will be led by Sandra Balseiro, who has a master's degree in Cell Biology and a degree in Biology from the University of Coimbra. Since 2005 she has had experience in medical device legislation, and in 2007 she became an ISO 13485 auditor, carrying out audits in accordance with EN ISO 13485 and EN ISO 9001, including applicable standards such as ISO 14971; IEC 62366, IEC 60601, IEC 62304, IEC 82304, ISO 14644, ISO 14648 since then. In addition, (2010-2021) Sandra is helping companies to certify their products (DMs and IVDs), including standalone software, invasive medical devices, active medical devices and class D, C and B IVDs. Sandra Balseiro also has experience as an assistant professor of human genetics, molecular biology and molecular pathology and has developed and certified several IVD tests based on PCR and RT-PCR techniques (2003-2016). Finally, in 2020, Sandra joined the Pedro Nunes Institute's Automation and Systems Laboratory, working as a regulatory specialist for medical devices and in vitro diagnostics. As head of the regulatory unit, Sandra supported more than 70 companies throughout the regulatory process for their devices.
The session will also be facilitated by Stephanie Batista, a LAS collaborator in medical device certification support services - specialising in Software as a Medical Device, software engineering, artificial intelligence and cybersecurity for medical devices. Stephanie is a Senior Technician in Biomedical Instrumentation and has a degree in Biomedical Engineering and Bioelectronics from the Coimbra Higher Institute of Engineering. She also has a postgraduate qualification in Medical Devices from the Coimbra School of Health Technology and has taken part in a wide range of training programmes in the areas of software development and validation, artificial intelligence and cybersecurity. Stephanie is involved in a number of national and international projects in various areas of engineering, such as computer science, robotics, electronics and biomedical engineering, with a particular focus on the application of Artificial Intelligence in software development. His experience covers the various phases of software development for medical devices and in vitro diagnostic medical devices, mainly in the area of UI/UX design, requirements engineering, risk management, validation, security and quality assurance (QA) of medical software, with experience in software development and automated testing, as well as in creating test protocols, defining scenarios and implementing relevant test cases.
LAS carries out Research and Technological Development and technology transfer activities in collaboration with companies in the areas of Embedded Systems, Collaborative Robotics, Internet of Bodies, Validation, Evaluation and Certification Support for medical devices.
For more information on medical device certification support services, visit this link