Noted 2024 Projects
In 2024 I helped 19 clients on multiple projects with their medical device software quality…
Software Design Plan
Software Requirements
Cybersecurity
Who we are
About Us
Luova Solutions, LLC is a consultancy specializing in medical device software. Founded by Curtis Wichern in 2019 and based in Utah, this company addresses a crucial gap Curtis observed: many software engineers lack a comprehensive understanding of how compliance with regulatory documentation contributes to the creation of safer medical device software products that are also easier to maintain.
What we offer
Luova Solutions Provides the Following Services
IEC 62304-Compliant Software Documentation
IEC 62304 outlines requirements for medical device software. We ensure the creation of safe and effective medical devices by adhering to these standards.
Medical Device Software Life-Cycle Processes
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FDA Software Documentation Guidance
The FDA sets specific expectations for medical device software documentation. We conduct risk analysis and implement appropriate cybersecurity measures.
Blog
Our Latest Blog
How do you hire technical…
How do you hire technical people? This is always a struggle, especially for start-up companies.…
What Documents are Needed to…
What Documents are Needed to be Compliant with IEC-62304? The European Standard for medical device…
