FDA Compliant Medical Device Custom Software Development

Gener8 Software is powered by The RND Group.

From idea to market, we cover the entire lifecycle of your software development to ensure FDA compliance and help build quality products that drive business success. Whether it’s a new idea that you want to bring to market or a technical assessment of your current solutions, our staff of mechanical, electrical, software and systems engineers with decades of experience will collaboratively bring your ideas to life.

Our customers have assurance that their products follow FDA requirements and provide quality diagnostics and care to their own customers.

Our customers span from startups to large medical device leaders. We maintain collaborative flexibility for fast-paced lean organizations and large enterprises where communication between multiple stakeholders across departments is critical. Our custom software solutions support FDA compliant products from  in-vitro diagnostics products (IVDs) to Software-as-a-Medical-Device (SaMD)  and Software-in-a-medical (SiMD) projects.

Browse Software Case Studies

Thousands of projects completed.

We’re proud to serve the Biotech, Medical, and Industrial markets.

Instruments & Devices
Microfluidic Cartridges & Consumables