Biomedical Engineer
Quality assurance, regulatory affairs.
Gianluca has more than 20 years of experience in the Medical Device industry, in the fields of R&D, Operations, Quality Assurance & Regulatory Affairs. At BEL he is involved in Quality Assurance & Regulatory Affairs (ISO9001, ISO13485, CE Marking, Medical Device Directive 93/42/EEC, In Vitro Diagnostic Directive 98/79/EEC, FDA 21CFR Part 820, Medical Device Regulation MDR) since 2001. He also has 15 years’ experience as Notified Body Lead Assessor for the medical devices, IVD and healthcare sectors and he is an Health Canada registered Lead Assessor since 2005. His expertise covers medical device design/manufacturing, regulatory strategy, post market and vigilance, Company start up, QMS design & certification, worldwide OEM/OBL collaborations, supply chain management, clean room manufacturing, sterilization, medical device packaging and labelling, process control.
Within SILKELASTOGRAFT, he will be responsible for regulatory assessments related to the novel Silkothane® graft.
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