Services

Software

Software as a Medical Device

Luova Solutions

Minimize your time-to-market significantly by ensuring correct procedures from the outset.

Do you have a top-notch software development team but lack experience with medical devices? Need help connecting the dots between medical device software documentation and FDA requirements? Let Luova Solutions handle the documentation of your Software as a Medical Device, allowing your engineers to focus on product development.

Ensuring quality in medical device software is vital from project inception to software retirement. The FDA and EU need software documentation to make sure your software as a medical device is safe, effective, and secure.

Uncertain about where to begin regarding software as a medical device? Collaborate with Luova Solutions to develop your software planning, risk management, cybersecurity, requirements, verification protocols, and reports, meeting FDA and EU regulations.

What we offer

Our 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.

Additionally

we can work with you to deliver the following documents:

Testimonial

Tremendous Partner

Curt was a tremendous partner getting our medical device off the ground in an efficient manner. He worked with us to streamline our design controls to meet the needs of our product development group without unnecessary fluff, and filled in multiple technical gaps that arose when writing the software and firmware for our device. He had no problems diving into a project mid-swing, and helped us avoid countless technical, quality, and operational pitfalls because of his technical knowledge of medical devices and startup experience. It was a true pleasure to work with him throughout this project, and it's clear he reduced our cost and timeline to market.