Software as a Medical Device510(k) SubmissionsSoftware Development LifecycleQuality Management SystemsSOP ConsultationStreamlining Documentation
Growing successful companies requires more than good ideas. You need partners as passionate about your mission as you are to get you where you want to go. Our committed teams drive technology solutions, growth, and outcomes for long-term success. We are the right technology partner to help you get from here to there.
What Sets Us Apart
Our commitment to making an impact drives our relationships with customers and our passion for innovation and performance.
SDLC
Complete software development life cycle (SDLC) capabilities
510(k) submissions
Proven process for 510k submissions, reducing submission time to as short as 80 days
Software as a Medical Device
Deep healthtech domain expertise, including regulatory and FDA compliance knowledge
Experience
Stability
Longevity and stability throughout the growth lifecycle
Partnership Model
Relationship-based partnership model to support customers’ internal teams
Reference Projects
WHAT OUR CLIENTS SAY
Bálint Szvetkó – P3 Globe
“We worked together with the IronRooster team on several large international projects. Their preparation, determination, professional background and hunger for success are exemplary, and because of these, they managed to become a recognized factor in the public procurement tenders announced by the UN and the EU in a short period of time. Accurate understanding of customer needs and professional orientation are extremely important to them. The project teams are built with maximum care and adapted to the specific requirements. The joint work with IronRooster takes place in a partnership atmosphere, helping and building each other, we are always looking forward - excitedly - to the next chapter.”
Project Manager - Haemonetics Corporation
“This release would not be possible without the heavy-lifting from the IronRooster team, who provided the expertise and talent to quickly learn and turn these two phases around. We also recognize those Haemonetics stakeholders who provided their support, education, and cross-training to this project alongside their regular daily duties.”
András Körmendi, CEO, RF Sparkling Kft. (Hungary)
“We worked together with IronRooster both as co-workers for a common customer and on a project where we were their customer. Our feeling was always that the projects were in good hands. They worked with thoroughly planned tasks, precise time estimates, professional code quality and swift communication. We received several great ideas to improve our product. Adapting to new technologies and special requirements were not an issue for them either. If you are looking for a great development experience, do not hesitate to contact IronRooster!”
Ken Krupa, VP of Analytics and Business Performance Management, Avid Marketing Group (USA)
“I have worked with IronRooster for over 5 years and truly appreciate their technical services and partnership. They support Avid Marketing Group in building, maintaining, and expanding upon a custom analytics portal to provide our clients with program performance results. I know that I can rely on them for continued support and innovation through scoping/requirements, documentation, project management, development, and testing. I consider them an extension of my team!”
András Sallai, CEO, Sharention (Hungary)
“The developer team is a great help for us. Developments are always on time and of the right quality. Project management is helpful, and always solves our problems.”
François Didry, Software Engineering Manager, INLOG (France)
“IronRooster has been helping Inlog for years in maintaining our complex software suite, mixing different health domains, user workflows, old and new technologies, and regulatory requirements. IronRooster has shown agility in providing the human resources that Inlog needed, and those resources have shown professionalism, motivation, and the will to do well despite the challenges.”