The RND Group is a Software Development company based in Indianapolis, Indiana that specializes in creating custom FDA-Regulated software with over 25 years of industry experience. The RND Group employs over 60 onshore Software Engineers with an average tenure of 15 years.  We have developed over 100 FDA approved medical devices ranging from Class I-III, SaMD and RUO devices.

Our services include software requirements definition, design and development,  verification, and validation for medical device software, as well as software regulatory consulting to help our clients with FDA regulations and cybersecurity. We are compliant with IEC 62304, ISO 13485, HIPPAA, IEC 62366, and CFR Part 820.

The RND Group has developed software for portable, POC, benchtop and large-scale analyzers. The RND Group’s software team can development software on any platform running any operating system (RTOS, Linux, Windows, Cloud), in a variety of languages. Our solutions are architected for maintainability and regulatory compliance.

We have worked with clients in the medical device industry, including startups, mid-size companies, and Fortune 500 companies to develop software for a range of medical devices, such as IVD, molecular,  imaging devices, patient monitoring systems, and many more.

The RND Group is part of Gener8 who offers complete engineering services from product development through manufacturing and focus on commercializing complex instruments and consumables. With this Full Spectrum of Engineering Excellence, The RND Group / Gener8 can be your one stop shop  for any Engineering project.