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Leonardo Ruggiero

AGFA

Former research engineer at Vrije Universiteit Brussel, Leonardo currently collaborates with the European Commission as Expert Evaluator of R&I TRL3-TRL5 H2020 project proposals.

In 2017, Leonardo joined Agfa Radiology Solutions as Post-Market Surveillance (PMS) Coordinator. At Agfa, he supports the PMS and Clinical Evaluation operational activities. He is also a stakeholder in the MDR transition program and represents the company in the PMS Task Force at COCIR.

Agfa Radiology Solutions supplies radiology departments of hospitals all over the world with traditional X-ray film, hardcopy film and printers, digital radiography equipment and image processing software.


Session:

Post-Market Surveillance of medical devices: from reactive to proactive

Location Einstein C Room Start / end time 2:00 pm to 2:45 pm

A medical device manufacturer is expected to continuously generate evidence of safety and performance of its medical devices on the market. Post-Market Surveillance is the key process within a Quality Management System (QMS) that ensures such expectations are met. Traditionally based on a reactive approach, the current way of designing and implementing PMS activities is challenged. Manufacturers are pushed to proactively collect relevant safety and performance information to continuously support clinical evidence. Proactivity shall be considered to generate valuable feedback for other two QMS vital processes: risk management and clinical evaluation. A question arises: can a manufacturer be proactive enough?