Suzanne Bloemsma is a seasoned professional with over 20 years of experience in the medical device industry, currently serving as the Regulatory Affairs Program Director at Philips Regulatory Affairs Centralized Services. In her pivotal role, Suzanne leverages her extensive expertise in quality assurance and regulatory...
Suzanne Bloemsma is a seasoned professional with over 20 years of experience in the medical device industry, currently serving as the Regulatory Affairs Program Director at Philips Regulatory Affairs Centralized Services. In her pivotal role, Suzanne leverages her extensive expertise in quality assurance and regulatory affairs to navigate the complexities of clinical trials, risk management, and medical device registration in both the EU and USA. Her deep understanding of regulatory frameworks allows her to provide invaluable support and guidance on clinical studies and the clinical evidence necessary for securing medical device clearances across Philips' diverse product lines.
One of Suzanne's key projects involves the development of a comprehensive Philips procedure for the investigational release of medical devices for use in clinical studies. This initiative is critical in ensuring that Philips maintains compliance with stringent regulatory requirements while advancing innovative solutions in healthcare. Her work not only enhances the efficiency of the regulatory process but also reinforces the company's commitment to delivering safe and effective medical devices to market.
Suzanne's expertise extends to software as a medical device, including artificial intelligence applications, as well as diagnostic and monitoring hardware. Her skills in supplier audits, compliance management, and quality system oversight are instrumental in maintaining Philips' high standards of quality and safety. By effectively managing design control and validation processes, she plays a crucial role in the commercialization of cutting-edge medical technologies. Suzanne's dedication to excellence and her proactive approach to regulatory challenges make her a key asset to Philips and the broader medical device community.
