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Medical Device Software Development & Regulatory.

We help Medtech companies create and clear Software as a Medical Device (SaMD). Additionally, we can develop your regulatory strategy, build your software (including AI/ML and cybersecurity), draft your design documents, and submit your FDA 510(k).

Our team of software engineers and regulatory consultants has been helping medical device companies get onto the market since 2012. We operate at the intersection of software engineering and regulatory guidance.

  • Min project size
    Undisclosed
  • Hourly rate
    Undisclosed
  • Employees
    10 - 49
  • Locations
    Austin, TX
  • Year founded
    Founded 2012

1 Locations

  • Austin , TX

Select Focus Area
Application Platforms
Linux server
50%
Frameworks and CMS
.NET
25%
Django
25%
IT Managed Services Focus
Security
100%
Product Design Focus
Programming & Scripting
C
15%
C#
15%
C++
15%
Java
15%
Python
15%
Typescript
15%
Rust
10%
Industries
Medical
100%
Clients

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Locations (1)

1101 West 34th St. #550 AustinTX, United States 78705

16 - 20

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