Marketa Shanelova, MBA
I am happy to offer support to medical device developers, manufacturers, and other economic operators with Quality Management Systems and Regulatory Affairs tailored to their specific needs.
I am a medical device industry enthusiast passionate about contributing to helping improve lives. I have been supporting clients in the area of Quality Management Systems and Regulatory Affairs as a consultant since 2021, working in the MedTech industry since 2009.
I have a medical background as a qualified radiographer, degree in health care management and over 12 years of experience from an international medical device company focused on development and manufacturing of mostly invasive high risk medical devices. I have held various quality management system, quality, and regulatory related roles, including a PRRC role, and I have gained a strong knowledge of EU and US requirements related to medical devices and project management skills working closely with development teams, production, marketing, EU Notified Bodies, Competent Authorities, US FDA, distributors, as well as customers.