Malena Costa, whose background is in Production Engineering, serves as Quality Manager at Focus, an engineering services company based in Montevideo, Uruguay. Focus specialises in the design and development of medical device hardware and software, supporting clients in achieving compliance with international standards such as ISO 13485 and IEC 62304. With a focus on integrating engineering practices with regulatory requirements, Malena works on developing efficient, compliant systems that enable faster and more reliable product development.