André Fazenda appointed QARA Manager for Cardiolife

André Fazenda joins Cardiolife as QARA (Quality Assurance & Regulatory Affairs) Manager, bringing extensive experience in medical device certification, regulatory compliance, and quality management.

In his new role, Fazenda will lead Cardiolife’s regulatory strategy and quality systems, ensuring compliance with EU MDR and FDA regulations. He joins from PeekMed, where he managed QMS certification under ISO 13485:2016 and led MDR and FDA regulatory processes for Software as a Medical Device (SaMD), including AI-powered solutions. Prior to that, he held key QARA roles at PROHS S.A., overseeing global medical device registrations across Europe, the USA, and Latin America.

With a Master’s degree in Bioinstrumentation and a Bachelor's in Biomedical Engineering, Fazenda brings a strong technical and regulatory foundation to Cardiolife. His appointment comes at a crucial time as the company strengthens its regulatory framework, with EU MDR certification in progress and FDA clearance as the next strategic milestone.