About Us

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.

Driven by this observation, Curtis aims to leverage his 30 years as a software engineer, the last 12 of those years as a medical device software engineer, along with his extensive background as a software developer in productivity, aerospace, accounting, entertainment, education, and life sciences. His focus has always been on streamlining business processes, documenting medical devices, and creating full-stack web platforms. Moreover, Curtis specializes in strategically applying medical device software standards to assist startup companies.

Risk Management

Curtis holds a certification in Risk Management from the American Society for Quality (ASQ) and possesses a comprehensive, hands-on understanding of standards such as IEC 62304 / 82304, ISO 13485 / 14971, and FDA 21 CFR 11 / 820.