Magda Kocot Mazur
A Medical Project Manager at Integrated Computer Solutions, Inc., Magda is passionate about managing multidisciplinary projects and developing medical devices that meet the client’s needs and regulatory requirements. She has hands-on experience in design, development, production and certification of class I, ll and class lll medical devices. In addition, she holds a degree in biomedical engineering and has extensive knowledge on medical device regulations.
Articles by Author
Verification and validation ensure software is safe, effective and meets all requirements and user needs.
Explore U.S and EU regulations intended to help developers create safe AI-based software.
Address issues relevant to mobile platforms, including OS compatibility, responsive design and cybersecurity.
Properly classifying your SaMD is crucial as it determines your medical device path to the market.
Software that meets the definition of a medical device is subject to a complex set of requirements.