Medical Device Software Development

Because medical device software is more than just code.

Developing software for medical devices requires unique skillsets. IronRooster is an established provider of regulated software services for healthcare and medical technology companies. Our team manages the entire medical device software lifecycle including planning, analysis, development, testing, support, documentation, and ensuring compliance with regulatory requirements. We create, optimize and implement effective and transparent processes to ensure medical solutions are approved and reach the market faster.

Skills

Full lifecycle custom software development for medical software (Class I, II, III / A, B, C)

Regulatory compliance with FDA 21 CFR Part 820, ISO 13485, IEC 62304

Compiling 510(K) documentation

Creating standard operating procedures (SOPs)

Are You Ready for a Solution?

This is a perfect opportunity to find the solution to your problems. Please feel free to request a free 30 minute consultation..

Are You Ready for a Solution?

This is a perfect opportunity to find the solution to your problems. Please feel free to request a free 30 minute consultation..
Iron Rooster Logo

Connect With Us

Our Offices

Office In the US :

1039 Chrome Rd.
Oxford, PA 19363
Office In Hungary:

Vasvári Pál u. 1/C
H-9024 Győr
+36-96-550-521