Magda Kocot

Magda Kocot

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.

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Regulatory Considerations for Medical Device Software

Monday, November 29, 2021 - 10:14  •  By Magda Kocot  •  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  •  medical device, SaMD

Software that meets the definition of a medical device is subject to a complex set of requirements.

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