2022 Projects Summary: Last year was a time of growth for me. I added more clients and finished some major projects. Here is a brief summary of the medical device projects I worked on during 2022.
Cybersecurity
I helped three medical device manufacturers create their cybersecurity hazard analysis, software bill of materials, and cybersecurity change management plans.
Auditing
I served as a software subject matter expert for an internal, on-site audit for a major medical device company. I audited both their product software and non-product software.
QMS
I helped four medical device manufacturers create their quality management systems from scratch; one was paper-based and the others used eQMS software solutions. Their products consisted of Software as Medical Devices and electro-mechanical devices.
I performed a gap analysis on an existing paper-based QMS for a contract manufacturer.
Design Documentation
I helped eight companies create product life-cycle documentation ranging from planning documents to risk analysis and design inputs to traceability matrices.
Compliance
I worked with a team to help a company navigate their 483 responses.
Combination Product
I worked with a team to prepare a combination product submission to the FDA, focusing on the summaries of their QMS and the device sections of the submission.
Training
I team-taught a multi-day course on medical device cybersecurity and solo-taught a multi-day course on non-product software validation.
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