Floryan Fantaccino

Floryan worked for 5 years at Hillo, a manufacturer of software medical devices for diabetic patients. He built the entire QARA strategy for their products, identified as IIa under the new regulations. His biggest challenge, beyond building the system, was to adapt this strategy to transform the product into a Class I and accelerate its time to market.

Since March 2023, Floryan has been Head of QARA at Theodo HealthTech, the e-health specialist unit of Theodo (a consulting and software development company). His role is to maintain ISO 13485 certification, in particular using the Agile method, and to support customers on various subjects including the creation, maintenance and improvement of a QMS using Agile methods.

Through his experience, Floryan has become an expert in the Agile method and its application to QARA issues, and in the development of DM software in accordance with current standards such as 62304.