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Luiz Levy, Director & Quality and Regulatory Affairs at Emergo
Manage episode 342526821 series 3399898
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Luiz Levy has over ten years of medical device industry experience, primarily focused on high-risk devices, including implantable devices, electrical medical equipment, and disposables subject to INMETRO Certification. Luiz’s background includes: implementing and auditing quality systems to B-GMP Regulation RDC 16/2013, ISO 13485:2016, Directive 93/42/EEC, Regulation (EU) 2017/745, FDA 21 CFR 807, FDA QSR 21 CFR 820, MDSAP-Medical device Single audit program; performing multiple local and foreign (US, Europe, Japan) audits to prepare companies for ANVISA inspections; assisting companies during ANVISA inspections; compiling medical device and IVD applications; clinical data review; compiling clinical evaluation reports and compiling and peer-reviewing market access reports.
As Director, Quality and Regulatory Affairs, Luiz has peer-reviewed more than 300 regulatory filings and reports, conducted multiple onsite audits on local and foreign manufactures, performed internal audits, and performed or reviewed more than 350 classifications/technical files of healthcare products, attended strategic meetings with ANVISA to help Agency on the final draft of new regulations (RDCs). Luiz is the designated Health Manager for Emergo’s Brazil Registration Holder services, and he additionally managers Emergo Brazil’s RDC 16/2013 quality system. Prior to Emergo, Luiz held RA/QA positions at CPL Medicals, Goen3, and Medics.
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