Andrzej Bujok

Andrzej Bujok is a Doctoral Researcher in the Regulated Software Research Centre His research focuses on understanding how business control management systems need to enhanced to fulfill the regulatory demands of the medical device industry and what practices organisations having ISO 13485 or a more generic quality management system (QMS) in place need to implement to satisfy the medical device regulations for software – either for a medical device containing embedded software or a medical device that consists entirely of software. The aim is to research what standards would be required – how the required standards relate to ISO 13485 and the other standards, then develop a framework based upon the gap between ISO 13485 practices to what is required – validate the framework using experts from the international medical device standards community and tailor the framework based upon feedback – once validated by international experts then perform trial implementations in customer environments and obtain feedback – and tailor until the framework is complete. In addition to safety standards the research takes into consideration security and interoperability as this is particularly important for devices that will be networked within a healthcare setting. Andrzej graduated with first class honours H-Dip in Science in Computing. He also received a certificate in software testing from the Irish Software Testing Board (License ISTB-9011-CTFL)