PANEL SESSION
Metrology for health: main challenges in making new technologies metrologically compliant
ORGANIZED BY
Loredana Cristaldi
Loredana Cristaldi
Polytechnic University of Milan
Nicola Giaquinto
Nicola Giaquinto
Polytechnic University of Bari
Luca Mari
Luca Mari
University of Castellanza
Metrology, technical standardisation and legal compliance are the three pillars on which accuracy, reliability and safety of medical devices are based. In this respect, new technologies pose a number of challenges, involving researchers, developers, manufacturers, and everyone with responsibilities in the use of such devices.
The panel will feature experts from top professionals in accreditation, certification, and technical standardization, who will share their insights and perspectives on the following topics.
- Artificial intelligence in testing and accreditation activities (ACCREDIA)
AI plays an ever-increasing role in measurements, including health measurements. The particular nature of the measurements carried out by AI poses delicate challenges, which starts int the accreditation of the bodies that must certify such measurements. What are the benefits and risks of measures with AI? What is the right way to balance and manage them?
Accredia (https://www.accredia.it/en/) is the Italian member of European Accreditation, and the single Accreditation Body for Italy. - Medical devices certification in Europe: what are we at? (IMQ)
Regulation (UE) 2017/745, known as MDR (medical device regulation), have introduced much stricter requirements for the safety and performance of all the medical devices to be marketed in European Union.
A uncertified medical device is useless, but certifying it is a new challenge, for both manufacturers and certification bodies. What are the challenges involved? How is the situation evolving? What about medical devices based on AI and new technologies?
IMQ (https://www.imq.it/en) is a leading company in the field of conformity assessment, and is one of the comparatively few Notified Body that can issue certificates for MDR. - Technical standardization in the field of brain-computer interfaces (CEI and IEC)
BCIs are devices that allow direct communication between the brain and external devices, such as prosthetics, computers, or robots. They pose significant challenges for metrology and technical standardization, such as how to measure brain signals, how to ensure interoperability and compatibility, and how to protect data privacy and security. What are the current state-of-the-art and future directions for technical standardization in the field of BCIs?
CEI (https://my.ceinorme.it) is the Italian official representative in IEC (https://iec.ch), the world’s leading organization for the preparation and publication of international standards in electrotechnology.
