Sofia Palm

Sofia Palm began their work experience in 2003 as a Development Engineer at CerBio Tech/Doxa, where they focused on the development of bioactive ceramic bone implants and implemented quality systems. Sofia then moved on to St Jude Medical in 2004 as a Material Technology Engineer, where they worked on the development and testing of new materials for pacemaker leads. In 2005, they transitioned to the role of Process Engineer at St Jude Medical, responsible for cleanroom processes and quality aspects. Sofia also obtained certifications in Six Sigma continuous improvement.

In 2010, Sofia joined BSI as a Technical Specialist and Certification Scheme Manager in the Vascular Team, where they were responsible for CE certification of medical devices. Sofia also conducted reviews of design dossiers and technical documentation for devices in the vascular area. Sofia was promoted to Senior Technical Specialist and Certification Scheme Manager, taking on additional responsibilities as a Clinical Evaluation Specialist and Certification Decision Maker. Sofia trained new employees and made final certification decisions based on the Medical Device Directive (MDD) and the Medical Device Regulation (MDR).

Sofia briefly worked at TÜV SÜD in 2022 as a Medical Device Expert and Product Reviewer before returning to BSI as a Senior Technical Specialist and Certification Scheme Manager in the Vascular Team. In 2023, they were promoted to Principal Technical Specialist and Certification Scheme Manager, acting as a mentor and using their expertise in various roles within the Vascular Team. Their main focus was on schemes such as the MDD, MDR, and UK MDR.

Throughout their career, Sofia has demonstrated expertise in technical specialization, certification scheme management, clinical evaluation, and certification decision making in the medical device industry, particularly in the vascular field.

Sofia Palm completed their compulsory schooling at Gärdeskolan in Ludvika from 1984 to 1993. Sofia then attended Högbergsskolan/VBU in Ludvika from 1993 to 1996, where they pursued a college education in Natural Science. After that, they enrolled at Aston University from 1999 to 2000 to complete their final year of BSc. in Applied and Human Biology with a focus on Molecular Biology. From 1996 to 2002, Sofia studied at Linköping University and obtained a Master of Science degree in Biotechnology. Additionally, in 2001, they attended ETH Zürich to work on their Master thesis focused on Biomaterials, completing it in 2002.