Celestina Bianco

Quality Assurance and Regulation Affair Director Werfen

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:

• ISO/TC210/JWG1 • ISO / TC 215 / JWG7

• MTE WGs: Software, Artificial Intelligence, Cybersecurity

• IMDFR Cybersecurity Working Group

Conference Day One

4:10 PM UNDERSTANDING HOW TO BALANCE CYBERSECURITY AND CLINICAL EXCELLENCE TO MAINTAIN DEVICE PERFORMANCE

Werfen is a worldwide leader in specialised diagnostics for Hemostasis, Acute Care Diagnostics and Autoimmunity. Through their OEM business, they research, develop and manufacture customised assays and biomaterials.

·        Applying QA/RA to ensure cybersecurity

·        Understanding how cybersecurity standards are applied globally and working with your notified bodies effectively

·        Building in contingency plans to managed necessary upgrades whilst managing the costs of doing so 

Check out the incredible speaker line-up to see who will be joining Celestina.

Download The Latest Agenda