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
Explore the SaMD Verification and Validation Process
Friday, February 25, 2022 - 10:41 "> • By Magda Kocot Mazur • SaMD, medical device
Verification and validation ensure software is safe, effective and meets all requirements and user needs.
Algorithms, Data Quality Key to Safe AI-based Software as a Medical Device
Monday, February 7, 2022 - 09:54 "> • By Magda Kocot Mazur • SaMD, medical device
Explore U.S and EU regulations intended to help developers create safe AI-based software.
Building Secure Medical Devices on Mobile Platforms
Friday, January 14, 2022 - 09:43 "> • By Magda Kocot Mazur • Medical, SaMD, Mobile
Address issues relevant to mobile platforms, including OS compatibility, responsive design and cybersecurity.
Regulatory Considerations for Medical Device Software
Monday, November 29, 2021 - 10:14 "> • By Magda Kocot Mazur • medical device, SaMD
Properly classifying your SaMD is crucial as it determines your medical device path to the market.
What You Need to Know About Developing Software as a Medical Device
Monday, November 15, 2021 - 10:22 "> • By Magda Kocot Mazur • medical device, SaMD
Software that meets the definition of a medical device is subject to a complex set of requirements.