Contact: Marshall Wenrich
Year Established: 2000
No. of Employees: 28
Key Clients: Infusion Pump companies, wireless data collection/sensors, start-ups to large device OEMs for class I, II, and some software-related class III devices

The Realtime Group is a design and testing firm certified to ISO 13485:2003 providing software testing, independent verification and validation testing, and design solutions related to medical instruments, diagnostics, and wireless products . Core services include software, hardware, safety, and system engineering; verification and validation testing; and project requirements management. We partner with leaders in the medical device industry to create and test innovative products that change lives. For more than 10 years, Realtime has thrived on repeat business through shared risk success stories.

Typical medical design products are microcontroller-based systems with embedded firmware interfacing (through USB or wireless) to larger system applications. Independent Validation Testing has covered the spectrum of software-intensive devices and manufacturing processes from sophisticated diagnostic instruments, infusion pumps, blood separators, organ transport, ultra-sonic generators, laser applications, and consumer healthcare products to IQ/OQ/PQ validation on breast implant manufacturing lines. Recent product failures reported in the news have emphasized the need for thorough end-user functional testing as part of the documentation for FDA and CE Mark regulatory submissions. Realtime produces that documentation.

We pride ourselves on having the expertise to accurately estimate total project cost and anticipate risks. Payments tied to frequent project milestones help ensure mutual motivation to meet end-customer business goals.