From startups to global leaders, and from initial product design to existing product updates

medical device services

 

We are masters of software development for FDA-regulated products. As seasoned experts who’ve worked on the development of the industry’s biggest successes, we’re able to apply our unique aggregated wisdom to our clients’ efforts, helping our clients get to market sooner, stronger, and better prepared for downstream product iterations.

Our experience has also made us experts in process control and forthright communication. We are fully aligned partners to your team, dedicated to thorough planning, rigorous execution, and being exactly the right partner for your needs.

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Specifics

  • Full lifecycle software development
  • FDA CFR Part 820/ISO-13485 compliant quality system
  • Engineers average 15+ years of experience
  • Requirements analysis, development and management
  • Software design, implementation, testing, QA, and verification
  • Project management
  • Design history file management
  • Maintenance and support