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Luisa Mella

Regulatory Affairs Manager @ Copan Group S.P.A.

Luisa Mella Contact Details

Location:
Italy
Work:
Regulatory Affairs Manager @ Copan Group S.P.A.
Quality Assurance Manager @ OVERMED SRL - Dental implants; implantable orthopedic devices
Complaint Manager-Quality Assurance Dept. @ Medacta International SA
Education:
110/110, Biomedical Engineering @ Politecnico di Milano
About:

Qualified Internal auditor Specialties: Regulatory Affairs: medical devices and IVDs: -Directives 93/42/EC and 98/79/EC -Submissions (Italy, EU, International) -Vigilance -21CFR820 -510k Quality Assurance: (ISO 9001:2008 ISO13485:2003; IEC 62304; ISO 14971)

Regulatory Affairs Manager @ -Managing the company conformity to IVD 98/79 and 93/42 Directive. -Technical files redaction and management -Complaint management: root cause analysis, customer’s communication, Regulatory assessment 

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