Sarah Mundim is located in Brasília, Brazil, and has over ten years of medical device industry experience, from low-risk to high-risk devices, including implantable devices, disposables and electrical medical equipment subject to INMETRO Certification.
Sarah’s background includes: compiling and reviewing applications for medical devices of all risk classes for submission to ANVISA; compiling and reviewing marketing submissions per Directive 93/42/EEC and EU Regulation 2017/745 (MDR); compiling and reviewing 510(k) submissions per the US FDA requirements; reviewing clinical data and compiling Clinical Evaluation Reports per the EU MDR requirements; and compiling and peer reviewing multi-market research reports.
As a consultant, Sarah has peer-reviewed numerous regulatory filings and reports and performed or reviewed more than 400 classifications/technical files of healthcare products. Prior to Emergo, Sarah worked as a QA Auditor and then as a Study Director for Bioagri Pharma, a toxicological test laboratory.
