Luiz Levy

Levy, RAC

Manager, Quality and Regulatory Affairs - Brazil

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, and MDSAP; 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; and compiling and peer reviewing market access reports. As Manager, Quality and Regulatory Affairs, Luiz has peer reviewed more than 200 regulatory filings and reports, conducted multiple onsite audits on local and foreign manufactures, performed internal audits, and performed or reviewed more than 300 classifications/technical files of healthcare products. Luiz is the designated Health Manager for Emergo by UL's Brazil Registration Holder services, and he additionally managers the RDC 16/2013 quality system. Prior to Emergo by UL, Luiz held RA/QA positions at CPL Medicals, Goen3, and Medics. Additionally, he teaches courses on ANVISA medical device and IVD regulations and quality system requirements at two post-graduate institutions.