Magda Kocot Mazur

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.

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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.

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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.

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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.

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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.

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