Spyrosoft / Spyro-Soft

Consulting Firm

Spyrosoft is a specialized FDA regulatory consulting firm with 12 years of experience. They focus on guiding medical device companies through the FDA 510(k) regulatory pathway, with deep expertise in Software as a Medical Device (SaMD) and Digital Health devices. Their services encompass comprehensive software and regulatory consulting to achieve successful 510(k) clearances for clients in the US ...

Experience: 12+ years

Professional Overview

Spyrosoft is a specialized FDA regulatory consulting firm with 12 years of experience. They focus on guiding medical device companies through the FDA 510(k) regulatory pathway, with deep expertise in Software as a Medical Device (SaMD) and Digital Health devices. Their services encompass comprehensi...

Core Specializations

Best suited for

• • MedTech companies seeking expert regulatory guidance

Experience signals

• Regions: US, EU
• Background: 12+ years of regulatory experience.

Cruxi view

With 12 years of experience as a consulting firm, Spyrosoft uniquely specializes in navigating the FDA 510(k) regulatory pathway specifically for Software as a Medical Device (SaMD) and other Digital Health devices. Their deep expertise is concentrated on Class II devices, offering comprehensive software and regulatory consulting to achieve successful 510(k) clearances for clients in both the US and EU. This focused approach ensures clients receive highly specialized guidance tailored to the complex and evolving landscape of digital health regulations, leveraging a firm's resources rather than an individual's.

This analysis is generated by Cruxi AI using public information and may not capture the full scope of the consultant's experience.