Sandra Balseiro

Sandra Balseiro (F), MsD, has a master degree in Cellular Biology and graduated in Biology from the University of Coimbra. Since 2005 has experience in medical devices regulation, and in 2007 became an ISO 13485 auditor, conducting audits according to EN ISO 13485 and EN ISO 9001 standards, including, applicable standards like ISO 14971; IEC 62366, IEC 60601, IEC 62304, IEC 82304, ISO 14644, ISO 14648 since then, Sandra is part of the teaching staff for postgraduate courses in Medical Devices and Clinical Research in Health Services at EstesC. 

Moreover, (2010-2021) Sandra is helping companies to certify their MD and IVD products, including standalone software, invasive medical devices, active medical devices and class D, C and B IVDs. Sandra Balseiro has also experience as assistant professor of human genetics, molecular biology and molecular pathology and has developed and certified several IVD tests based on PCR and RT-PCR techniques (2003-2016). 

Finally, in 2020, Sandra integrated the Laboratory for Automation and Systems from Instituto Pedro Nunes, acting as medical devices and in vitro diagnostics regulatory expert. As the responsible of the regulatory unit, Sandra Balseiro has supported more than 100 companies throughout their devices regulatory process.

(ORCID: 0000-0003-3721-8233) - Coordinator of the Medical Devices Regulatory-support unit (MDRu) of Instituto Pedro Nunes.