BoneEasyRegulatory and quality affairs
Nov. 2016 - Nov. 2023Arada. OvarDuring the time I've worked at BoneEasy, I was able to create and implement a Quality Management System (ISO 13485 and MDR 745/2017) for the registration and conformity for market of custom made medical devices, class IIb, manufactured by metal additive manufacturing techniques, on Dental and Maxillo Facial field. the company is settled in Portugal but sells worldwide and for that reason I was also part of the team responsible for FDA approval process as well as per Central America, EMEA, Anvisa and Asia countries registrations in order to get allowance for BoneEasy devices to enter on that markets, fulfilling all regulamentar demandings.