About

Brittany Michael is a highly experienced and accomplished medical device professional with a BS in Chemical Engineering. She began her career in software before transitioning to medical devices, where she has worked on a wide range of products, including Class I-III medical devices (blood therapy, stem cell products, electrosurgery, implants), combination devices (autoinjectors, on-body devices), in-vitro diagnostics (Covid-19 antigen and antibody, influenza, STIs), and SaMD (wearables, applications).

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Brittany is a leader in risk management, having remediated entire product offerings at companies as large as $1 billion in revenue. She has helped determine regulatory pathways, risks, and has contributed to 510(k) submissions. She has defined and created design control systems and the associated work instructions, templates, and SOPs. She has owned the DHF for product portfolios, had roles in usability/validation, and performed verification. She has owned all aspects of risk management from remediating the risk management program to conducting or participating in FMEAs, risk-benefit analyses. She is an ISO 62304 and ISO 14971 subject matter expert.

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In addition to her expertise in medical devices, Brittany also provides consulting expertise in the areas of chemical extraction, automotive modification, software management, and patent preparation under the direction of a patent agent or patent lawyer.

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Brittany is a highly motivated and results-oriented professional with a proven track record of success in a variety of challenging and demanding environments. She is a team player with excellent communication and interpersonal skills. She is also a creative problem solver and is able to think outside the box to develop innovative solutions to complex problems.

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Brittany is a valuable asset to any organization and would be an excellent addition to your team.