Priscila Pedroso Email & Phone Number

São Paulo, Brasil

International Product auditor and technical approval of certification process of medical devices according INMETRO certification program and ANVISA registration process of medical devices, such as electro medical equipment, needles, syringes and infusion sets. Certifier responsible approval the certification process of medical devices according INMETRO certification program and ANVISA registration process of. Medical devices, such as electro medical equipment and non-active devices as needles, syringes and infusion setsFocus on the analysis, interpretation and contributions to new and proposed regulations ANVISA; INMETRO; CE Mark; FDA.

Tüv Rheinland Do Brasil Ltda

- Lead Auditor qualified in EN ISO 13485 and EN ISO 9001.- Perform certification activities to active and non activie medical devices, companies to obtain clearance to sell the products at Europe (CE Marking).- Perform activities related to Certification to electro medical devices aiming commercializing products on Brazil. These activities are based on scientific and technologic strategies following INMETRO accreditation and ANVISA (National Vigilance System Agency).- Responsible for conducting training and qualification of international auditor according INMETRO certification rules. - Carried out international factory inspections in Germany, Belgium, Netherland, Italy, Poland and China.

Responsible for sterility test in products as: dental implants, orthopedic implants and sterile drug product.- Validation bioburden test, sterility test in sterile product such as dental implants, orthopedic implants and sterile drug product - Environmental microbiology in clean-room in pharmaceutical companies.- Counts of bacteria and yeasts in raw material.- Control environment of air according to RDC 9 (ANVISA – Brazilian requirements), in environment with air conditioning such as office and old building

Mba, Environmental Management

Bachelor Degree In Biological Science