Gener8 | The RND Group

The RND Group, now integrated with Gener8, specializes in custom software development for FDA-regulated medical devices. With over 25 years of experience in the healthcare industry, the company develops software solutions ranging from in vitro diagnostic (IVD) products to Software as a Medical Device (SaMD) applications. The company operates under IEC 62304-compliant quality management systems and maintains expertise in FDA regulatory pathways.

The company offers turnkey software development services including requirements definition, full lifecycle development, verification testing, and regulatory documentation. Their technical capabilities span embedded device software, cloud-based medical device data systems, laboratory information system (LIS) integration, and instrument control software. The RND Group has supported clients through FDA approval processes and has worked on projects processing over 30,000 physician orders annually and monitoring more than 1 million patients.

Following integration with Gener8, The RND Group now operates as part of a larger product development organization that combines regulated software expertise with engineering and manufacturing capabilities. Case studies demonstrate experience with immunohistochemistry automation, cardiac monitoring systems, molecular diagnostics, and next-generation sequencing platforms.

Choose The RND Group when FDA regulatory compliance is non-negotiable and the project requires demonstrated experience with IEC 62304 software development lifecycle. Their packaged FDA Readiness Assessment service provides value for companies approaching regulatory submission, while their Application Accelerator and LIS Connector products can reduce time-to-market for common medical device software needs.

Expect a structured approach with comprehensive documentation suitable for regulatory review. The team can scale from 2 to 10 resources based on project phase, making them suitable for companies without internal regulated software development capabilities who need turnkey delivery including verification testing and design history files.

The RND Group operates exclusively in regulated healthcare, specifically medical device software development under FDA oversight. Their expertise centers on in vitro diagnostics (IVD), Software as a Medical Device (SaMD), immunohistochemistry instruments, molecular diagnostics, cardiac monitoring systems, and laboratory automation. The company maintains HIPAA compliance and develops solutions for pathology labs, clinical laboratories, and point-of-care testing environments.

Case studies demonstrate work across multiple healthcare verticals including cardiology (Holter monitors processing data for 1M+ patients), oncology (NGS companion diagnostics), and infectious disease testing (molecular diagnostics). Their LIS Connector product specifically addresses healthcare interoperability requirements for medical device integration with laboratory and EHR systems.

Medical device manufacturers, diagnostic equipment companies, and digital health organizations developing Class II or Class III devices requiring FDA clearance or approval. Companies at any stage from early development through post-market support who need software development expertise combined with deep regulatory knowledge. Particularly suitable for firms developing laboratory automation, molecular diagnostics, or connected medical devices requiring cloud infrastructure.