Director of Quality and Regulatory Affairs, Clinical Software - Werfen
Real-world AI applications in patient care and MedTech decision making
Wednesday 15 May 12:00 - 12:50
Dr. Celestina Bianco is Director of Quality at Werfen CSW.
CSW is a private company within the Werfen Group, developing SW to be integrated in IVD products, or to be distributed as SW Medical products. CSW is also legal manufacturer of two MDSW.
With a degree in Bio Physics, and some years in Artificial Intelligence, since 1987 Celestina has worked in the field of Health Care software, initially in R&D and later in the area of Quality.
She supported the definition and control of the Quality System at CSW and other companies.
At CSW, she runs the Software Quality, including Quality Control, Quality Assurance and Regulatory Affairs.
Celestina has regularly presented papers at international conferences,and gives seminars.
She collaborates in international committees:
o ISO/TC210/JWG1 - Participating in WG for definition of ISO 14971, ISO 24971
o ISO / TC 215 / JWG7 - IEC / SC 62A WG: Safe, effective and secure health software and health IT systems, including those incorporating medical devices
o Participating in WG for definition of ISO 62304: Health Software - Software Life Cycle processes
o Attending meetings of: IEC 80001-1 ED2 Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software - Part 1: Application of risk management
o Attending meetings of: ISO 81001-1 ED1: Health software and health IT systems safety, effectiveness and security - Foundational principles, concepts and term
o MTE Software Working Group (IVD & MD)